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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05839626
Registration number
NCT05839626
Ethics application status
Date submitted
31/03/2023
Date registered
3/05/2023
Titles & IDs
Public title
A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
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Scientific title
First-in-human, Open-label Phase 1/2 Study to Investigate Safety and Efficacy of SAR445514, an NKcell Engager (NKCE) Targeting B-cell Maturation Antigen (BCMA) in Monotherapy in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and in Relapsed/Refractory Light-chain Amyloidosis (RRLCA)
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Secondary ID [1]
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U1111-1279-2985
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Secondary ID [2]
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TCD17710
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma
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Amyloid Light-chain Amyloidosis
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Condition category
Condition code
Cancer
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Other cancer types
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Metabolic and Endocrine
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Other metabolic disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Metabolic and Endocrine
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Metabolic disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAR445514
Experimental: SAR445514 RRMM Dose escalation phase (Part 1a) - SAR445514 will be administered to participants with relapsed/refractory multiple myeloma (RRMM) using subcutaneous route (SC)
Experimental: SAR445514 RRLCA Dose escalation phase (part 1b) - SAR445514 will be administered to participants with relapsed/refractory light chain amyloidosis (RRLCA)) using subcutaneous route (SC)
Experimental: SAR445514 Dose level A (part 2) - SAR445514 will be administered to participants with relapsed/refractory multiple myeloma (RRMM) using subcutaneous route (SC)
Experimental: SAR445514 Dose level B (part 2) - SAR445514 will be administered to participants with relapsed/refractory multiple myeloma (RRMM) using subcutaneous route (SC)
Experimental: SAR445514 RRMM Dose expansion (part 3a) - SAR445514 will be administered to participants with relapsed/refractory multiple myeloma (RRMM) using subcutaneous route (SC)
Experimental: SAR445514 RRLCA Dose expansion (part 3b) - SAR445514 will be administered to participants with relapsed/refractory light chain amyloidosis (RRLCA) using subcutaneous route (SC)
Treatment: Drugs: SAR445514
Powder for solution for injection. Sub Cutaneous administration.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose escalation (part 1a - RRMM) Presence of dose limiting toxicities (DLT)
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Assessment method [1]
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DLTs will be defined using NCI CTCAE version 5.0 or ASTCT criteria for CRS or ICANS.
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Timepoint [1]
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Cycle 1 - 4 weeks per cycle
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Primary outcome [2]
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Dose escalation (part 1a - RRMM) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
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Assessment method [2]
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Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
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Timepoint [2]
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From Baseline to end of follow-up (approx. 15 months)
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Primary outcome [3]
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Dose optimization (part 2 - RRMM) Overall response rate (ORR)
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Assessment method [3]
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ORR is defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria, after the last participant is treated for at least 4 cycles or prematurely discontinued.
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Timepoint [3]
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Cycles 1 to 4 - 4 weeks per cycle
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Primary outcome [4]
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Dose escalation (part 1b - RRLCA) Presence of dose limiting toxicities (DLT) at cycle 1
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Assessment method [4]
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Timepoint [4]
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Cycle 1 - 4 weeks per cycle
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Primary outcome [5]
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Dose escalation (part 1b - RRLCA) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
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Assessment method [5]
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Timepoint [5]
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From baseline to end of follow-up (approx. 15 months)
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Primary outcome [6]
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Dose expansion (part 3 - RRMM) Overall response rate (ORR)
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Assessment method [6]
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ORR is defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria.
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Timepoint [6]
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Cycles 1 to 4 - 4 weeks per cycle
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Primary outcome [7]
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Dose expansion (part 3-RRLCA) Hematological response (HR)
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Assessment method [7]
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HR is defined as the proportion of participants with sCR, CR, VGPR, and PR according to the European society of hematology/International society of hematology working group guidelines.
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Timepoint [7]
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Cycles 1 to 4 - 4 weeks per cycle
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Secondary outcome [1]
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Dose escalation (part 1 - RRMM) Overall response rate (ORR)
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Assessment method [1]
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ORR defined as the proportion of participants with sCR, CR, VGPR, and PR according to the 2016 IMWG criteria.
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Timepoint [1]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [2]
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Dose optimization (part 2 - RRMM) Presence of dose limiting toxicities (DLT)
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Assessment method [2]
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Timepoint [2]
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Cycles 1 to 4 - 4 weeks per cycle
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Secondary outcome [3]
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Dose optimization (part 2 - RRMM) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
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Assessment method [3]
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Treatment-emergent adverse events (AEs) are defined as AEs that develop, worsen, or become serious during the treatment period. The treatment period is defined as the time from first dose of study treatment up to 30 days after last dose of study treatment.
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Timepoint [3]
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From first dose of study treatment up to 30 days after last dose of study treatment (approx. 1 year with cycle of 28 days)
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Secondary outcome [4]
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Dose optimization & expansion (Part 2 & Part 3a - RRMM) Very Good Partial Response (VGPR) or Better Rate
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Assessment method [4]
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VGPR is defined as the proportion of participants with sCR, CR, and VGPR according to the 2016 IMWG criteria.
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Timepoint [4]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [5]
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Dose optimization & expansion (Part 2 & Part 3a - RRMM) Duration of response (DOR)
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Assessment method [5]
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DOR is defined as the time from the date of the first response to the date of the first occurrence of progressive disease (PD as determined by the investigator or death from any cause, whichever happens first. DOR is determined only for participants who have achieved a response (PR or better).
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Timepoint [5]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [6]
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Dose optimization & expansion (Part 2 & Part 3a - RRMM) Time to first response (TT1R)
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Assessment method [6]
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TT1R is defined as the time from the date of the first response to the date of the first occurrence of progressive disease (PD as determined by the investigator or death from any cause, whichever happens first. DOR is determined only for participants who have achieved a response (PR or better).
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Timepoint [6]
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Cycle 1 to first progressive disease or end of treatment whichever comes first (approx. 1 year with cycle of 28 days)
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Secondary outcome [7]
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Dose optimization & expansion (Part 2 & Part 3a -RRMM) Time to best response (TTBR)
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Assessment method [7]
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TTBR is defined as the time from the first administration of the IMP to the date of first occurrence of best overall response (PR or better that is subsequently confirmed.
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Timepoint [7]
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Cycle 1 to first progressive disease or end of treatment whichever comes first (approx. 1 year with cycle of 28 days)
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Secondary outcome [8]
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Dose optimization & expansion (Part 2 & Part 3a - RRMM) Progression free survival (PFS)
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Assessment method [8]
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PFS is defined as the time from the date of the first administration of the IMP to the date of first documentation of progressive disease or the date of death from any cause, whichever comes first. Responses will be determined according to IMWG criteria. Progression based on paraprotein will be confirmed based on two consecutive assessments.
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Timepoint [8]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [9]
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Dose optimization & expansion (Part 2 & Part 3a - RRMM) Overall survival (OS)
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Assessment method [9]
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OS is defined as the time from the date of the first administration of the IMP to death from any cause
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Timepoint [9]
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Cycle 1 to end of follow-up or death (approx. 15 months with cycle of 28 days)
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Secondary outcome [10]
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Dose optimization & expansion (Part 2 & Part 3a - RRMM) Clinical benefit rate (CBR)
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Assessment method [10]
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CBR is the rate of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months from the first IMP administration determined by the Investigator per IMWG 2016 criteria.
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Timepoint [10]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [11]
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Dose escalation (part 1b - RRLCA) Overall Hematological Response (OHR)
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Assessment method [11]
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OHR is defined as the proportion of participants with CR, VGPR, and PR according to the International Society of Amyloidosis guidelines (ISA 2012).
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Timepoint [11]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [12]
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Dose extension (part 3b - RRLCA) Hematological complete response rate (HCR).
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Assessment method [12]
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HCR is defined as the proportion of participants with complete response according to the ISA 2012.
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Timepoint [12]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [13]
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Dose extension (part 3b - RRLCA) Hematological very good partial response rate or better (HVGPR)
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Assessment method [13]
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HVGPR defined as proportion of participants with very good partial response and CR as per ISA 2012 criteria
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Timepoint [13]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [14]
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Dose expansion (part 3b - RRLCA) Overall survival (OS)
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Assessment method [14]
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OS is defined as the time from the date of study entry to death from any cause.
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Timepoint [14]
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Cycle 1 to death or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [15]
0
0
Dose expansion (part 3b - RRLCA) Progression-Free Survival (PFS)
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Assessment method [15]
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PFS is defined as time from the time from the first administration of the IMP to any of the following: hematological progression, major organ progression (cardiac, kidney or liver) according to ISA 2012 criteria or death by any cause.
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Timepoint [15]
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Cycle 1 to first progressive disease (organ or hematological) or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [16]
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Dose expansion (part 3b - RRLCA) Time to first hematological response (TT1HR)
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Assessment method [16]
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TT1HR is defined as the time from the first administration of the IMP to the date of first hematological response (PR or better) that is subsequently confirmed.
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Timepoint [16]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [17]
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0
Dose expansion (part 3b - RRLCA) Duration of hematological response (DOHR)
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Assessment method [17]
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DOHR is defined as time from the time from the first administration of the IMP to any of the following: hematological progression, major organ progression (cardiac, kidney or liver) according to ISA 2012 criteria or death by any cause.
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Timepoint [17]
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0
Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Secondary outcome [18]
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0
Dose expansion (Part 3 - RRMM & RRLCA) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
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Assessment method [18]
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Treatment-emergent adverse events (AEs) are defined as AEs that develop, worsen, or become serious during the treatment-emergent period.
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Timepoint [18]
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From first dose of study treatment up to 30 days after last dose of study treatment (approx. 15 months with cycle of 28 days)
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Secondary outcome [19]
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Incidence rate of infusion associated reactions (IARs)
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Assessment method [19]
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0
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Timepoint [19]
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From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)
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Secondary outcome [20]
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Incidence rate of injection site reactions (ISR)
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Assessment method [20]
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Timepoint [20]
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From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)
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Secondary outcome [21]
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0
Incidence of laboratory abnormalities
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Assessment method [21]
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0
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Timepoint [21]
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From cycle 1 to end of follow-up (approx. 15 months with cycle of 28 days)
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Secondary outcome [22]
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0
Assessment of pharmacokinetics (PK) parameter of SAR445514: Ctrough
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Assessment method [22]
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Timepoint [22]
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From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)
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Secondary outcome [23]
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Assessment of pharmacokinetics (PK) parameter of SAR445514: AUClast
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Assessment method [23]
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Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to time of the last concentration observed above the lower limit of quantification (ie, Clast)
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Timepoint [23]
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From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)
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Secondary outcome [24]
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0
Assessment of pharmacokinetics (PK) parameter of SAR445514: Cmax
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Assessment method [24]
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Maximum observed concentration
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Timepoint [24]
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From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)
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Secondary outcome [25]
0
0
Assessment of pharmacokinetics (PK) parameter of SAR445514: Tmax
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Assessment method [25]
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First time to reach Cmax
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Timepoint [25]
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From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)
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Secondary outcome [26]
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Incidence of anti-drug antibody (ADA) against SAR445514
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Assessment method [26]
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0
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Timepoint [26]
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From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)
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Secondary outcome [27]
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0
Dose extension (Part 3 - RRMM & RRLCA) Minimum Residual Disease (MRD) negativity rate
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Assessment method [27]
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MRD status in participants with response of VGPR or better
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Timepoint [27]
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Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)
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Eligibility
Key inclusion criteria
Participants must have a documented diagnosis of multiple myeloma (Part 1a, 2, and 3a) or light chain amyloidosis (Part 1b and 3b).
Participants with RRMM (Part 1, 2, and 3a)
* Participants with measurable disease for RRMM
* Participants with MM must have received at least 2 prior lines of therapy which must include at least 2 consecutive cycles of a second or third generation immunomodulator, steroid, proteasome inhibitor and anti-CD38 monoclonal antibody (MoAb).
* Participants must have documented evidence of progressive disease (PD), as per IMWG 2016 criteria.
Participants with RR LCA (Part 1b and 3b) must have received at least 1 prior line of treatment comprising at least 1 proteasome inhibitor.
* Participants with measurable disease according to ISA 2012.
* Participants must have documented evidence of progressive disease (PD), as per ISA 2012 criteria.
* One or more organ impacted by amyloidosis as per National comprehensive cancer network (NCCN) guidelines.
For dose escalation, body weight within 40 to 120 kg
Capable of giving signed informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
* Primary refractory MM defined as participants who never achieved at least a minimal response with any treatment during the disease course
* Second primary malignancy
Participants with RRMM (Part 1a, 2, and 3a)
* For MM participants, primary systemic LCA and plasma cell leukemia
* For MM participants, congestive heart failure (New York Heart Association [NYHA]) Grade =II; cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition
Participants with RR LCA (Part 1b and 3b)
* For LCA participants, evidence of clinically significant cardiovascular condition, defined as one or more of the following:
1. N-terminal prohormone of brain natriuretic peptide (NT-proBNP) >8500 ng/mL
2. New York Heart Association (NYHA) classification III or IV heart failure
3. Heart failure that, in the opinion of the Investigator, is not primarily related to LCA cardiomyopathy (including, but not limited to, ischemic heart disease, uncorrected valvular disease, infections)
4. Prior event (history) in the last 6 months of acute coronary syndrome, myocardial infarction or unstable angina as well as participants who during the last 6 months experienced a percutaneous cardiac intervention with stent and/or a coronary artery bypass
5. Hospitalization in the last 4 weeks prior to treatment related to a cardiovascular event
6. Participants with prior history of arrhythmia and/or cardiac conduction disorders for which a pacemaker or an implantable cardioverter defibrillator (ICD) is required but has not been placed. This includes, but may not be limited to, sustained ventricular tachycardia, association of an atrioventricular, or sinoatrial nodal dysfunction
* For LCA participants, a systolic blood pressure <100 mmHg or a diastolic blood pressure <55 mmHg.
* For LCA participants: previous or current diagnosis of symptomatic MM, including the presence of lytic bone disease, plasmacytomas, =60% plasma cells in the BM, or hypercalcemia.
All participants
* Uncontrolled infection within 14 days prior to study treatment.
* Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A (defined as positive hepatitis A antigen or positive IgM); HIV serology at screening will be tested for participants in countries where it is required by local regulations.
* Uncontrolled or active hepatitis B virus (HBV) infection: participants with positive B surface antigen (HBsAg) and/or HBV deoxyribonucleic acid (DNA)
* Active hepatitis C virus (HCV) infection: positive HCV ribonucleic acid (RNA) and negative anti-HCV.
Prior/concomitant therapy
* Any anti-MM drug treatment within 14 days before study treatment
* Prior allogenic hematopoietic stem cell (HSC) transplant with active graft-versus-host disease (GvHD) (GvHD any grade and/or being under immunosuppressive treatment within the last 2 months prior to first IMP).
* Any major procedure within 14 days before the initiation of the study treatment
* Administration of an anti-CD38 monoclonal antibody (isatuximab or daratumumab) less than 90 days prior to the first administration of study treatment.
* Administration of an anti-BCMA agent (including, but not limited to, CAR T-cells, TCEs, antibody drug conjugate) less than 21 days prior to the administration of study treatment.
* Unresolved toxicities from prior anticancer therapy, defined as not having resolved to CTCAE Version 5.0 Grade 1, at the exception of residual Grade 2 peripheral neurotoxicity related to bortezomib and/or thalidomide and considered as stable.
* Participants with a contraindication to dexamethasone.
Prior/concurrent clinical study experience
* Received any other investigational drugs or prohibited therapy for this study within 28 days or 5 half-lives from study treatment, whichever is shorter
Diagnostic assessments
* Hemoglobin <8 g/dL (5.0 mmol/L)
* Platelets <50 × 10^9/L (not permissible to transfuse a participant within 1 week prior to the screening platelet count to reach this level).
* Absolute neutrophil count (ANC) <1000 µL (1 × 10^9/L).
* Creatinine clearance <30 mL/min (Modification of Diet in Renal Disease Formula).
* Total bilirubin >1.5 × upper limit of normal (ULN) (unless the subject has documented Gilbert syndrome in which case direct bilirubin should not be >2.5 × ULN).
* Aspartate aminotransferase (AST/SGOT) or Alanine aminotransferase (ALT/SGPT) >2.5 × ULN.
* Participants with Grade 3 or 4 hypercalcemia (corrected serum calcium of >12.5 mg/dL; >3.1 mmol/L; ionized calcium >1.6 mmol/L; or requiring hospitalization) will not be eligible unless participants recover to Grade 2 or less under anti-hypercalcemia treatment.
Other exclusions
* Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
* Participant not suitable for participation, whatever the reason, as judged by the Investigator
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/03/2028
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Actual
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Sample size
Target
111
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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0
Investigational Site Number : 0360001 - Wollongong
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Recruitment hospital [2]
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Investigational Site Number : 0360002 - Richmond
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Recruitment postcode(s) [1]
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0
2500 - Wollongong
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Recruitment postcode(s) [2]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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0
Belgium
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State/province [1]
0
0
Anderlecht
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Country [2]
0
0
Belgium
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State/province [2]
0
0
Antwerpen
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Country [3]
0
0
Czechia
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State/province [3]
0
0
Brno
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Country [4]
0
0
Czechia
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State/province [4]
0
0
Ostrava - Poruba
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Country [5]
0
0
Hungary
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State/province [5]
0
0
Budapest
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Country [6]
0
0
Italy
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State/province [6]
0
0
Lombardia
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Country [7]
0
0
Spain
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State/province [7]
0
0
Cantabria
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Country [8]
0
0
Spain
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State/province [8]
0
0
Cataluña
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Country [9]
0
0
Spain
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State/province [9]
0
0
Barcelona
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Country [10]
0
0
United Kingdom
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State/province [10]
0
0
Birmingham
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Country [11]
0
0
United Kingdom
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State/province [11]
0
0
London
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Country [12]
0
0
United Kingdom
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State/province [12]
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0
Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA). The study will comprise 3 parts: A dose escalation phase (Part 1) in RRMM participants (Part 1a) that will evaluate several doses administered to determine 2 doses that will be tested in the dose optimization part. A dose escalation will also be done in RRLCA participants (Part 1b) but started sequentially after the end of the dose escalation in RRMM participants. This dose escalation will evaluate the 2 doses planned to be used in dose optimization in RRMM, to ensure those doses are safe also for RRLCA participants. A dose optimization phase (Part 2) that will be evaluating 2 doses determined from Part 1 to determine the preliminary recommended Phase 2 dose (pRP2D) and schedule for SAR445514 in RRMM. A dose expansion phase (Part 3) that will evaluate the preliminary efficacy of pRP2D and schedule for SAR445514 in RRMM (Part 3a) and RRLCA (Part 3b). Approximately 111 participants will be enrolled and treated by study intervention and separated as such: Part 1a: Approximately 30 to 40 participants Part 1b: Approximately 6 to 12 participants Part 2: Approximately 30 participants Part 3a: Approximately 15 participants Part 3b: Approximately 14 participants
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Trial website
https://clinicaltrials.gov/study/NCT05839626
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Contact person for public queries
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Trial Transparency email recommended (Toll free for US & Canada)
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800-633-1610
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05839626