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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05862012




Registration number
NCT05862012
Ethics application status
Date submitted
4/05/2023
Date registered
17/05/2023

Titles & IDs
Public title
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma
Scientific title
A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
ISB 2001-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ISB 2001
Treatment: Drugs - ISB 2001

Experimental: Part 1: Dose Escalation - Participants with R/R MM will be administered ISB 2001 weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose in Cycle 1 on Day 4. Treatment cycle duration is 28 days. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study

Experimental: Part 2: Dose Expansion - Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study.


Treatment: Drugs: ISB 2001
Participants will receive escalating doses of ISB 2001

Treatment: Drugs: ISB 2001
Participants will receive injection of ISB 2001 as determined in Part 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to 18 months
Primary outcome [2] 0 0
Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)
Timepoint [2] 0 0
Up to 28 days
Secondary outcome [1] 0 0
Maximum Concentration (Cmax) of ISB 2001 in Serum
Timepoint [1] 0 0
Up to 28 days
Secondary outcome [2] 0 0
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum
Timepoint [2] 0 0
Up to 28 days
Secondary outcome [3] 0 0
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum
Timepoint [3] 0 0
Up to 28 days
Secondary outcome [4] 0 0
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum
Timepoint [4] 0 0
Up to 28 days
Secondary outcome [5] 0 0
Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)
Timepoint [5] 0 0
Baseline to 18 months
Secondary outcome [6] 0 0
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Timepoint [7] 0 0
18 months
Secondary outcome [8] 0 0
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Timepoint [8] 0 0
18 months
Secondary outcome [9] 0 0
Time to Progression (TTP)
Timepoint [9] 0 0
18 months
Secondary outcome [10] 0 0
Time to Next Treatment (TTNT)
Timepoint [10] 0 0
18 months
Secondary outcome [11] 0 0
Time to Response (TTR)
Timepoint [11] 0 0
18 months
Secondary outcome [12] 0 0
Progression Free Survival (PFS)
Timepoint [12] 0 0
18 months
Secondary outcome [13] 0 0
Overall Survival (OS)
Timepoint [13] 0 0
18 months

Eligibility
Key inclusion criteria
1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
3. Must have adequate hematologic, hepatic, renal, and cardiac functions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active malignant central nervous system involvement
2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
3. History of autoimmune disease requiring systemic immunosuppressive therapy
4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [2] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
India
State/province [3] 0 0
Bangalore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ichnos Sciences SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ichnos Sciences Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
(315) 583-1249
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05862012