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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04557150




Registration number
NCT04557150
Ethics application status
Date submitted
17/09/2020
Date registered
21/09/2020

Titles & IDs
Public title
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
Scientific title
An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2020-002012-46
Secondary ID [2] 0 0
BP42233
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Forimtamig

Experimental: Part I: Dose Escalation - Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.

Experimental: Part II: Dose Expansion - Dose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase.


Treatment: Drugs: Forimtamig
Forimtamig will be administered via IV/SC administration. The RP2Ds determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. Forimtamig will be administered as per the dosing schedule defined in Part I.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to 104 weeks
Primary outcome [2] 0 0
Percentage of Participants with Dose Limiting Toxicities (DLTs)
Timepoint [2] 0 0
Cycle 1 Day 1 up to Cycle 1 Day 35
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 104 weeks
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 104 weeks
Secondary outcome [3] 0 0
Progression-Free Survival (PFS)
Timepoint [3] 0 0
Up to 104 weeks
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to 104 weeks
Secondary outcome [5] 0 0
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig
Timepoint [5] 0 0
Up to 104 weeks
Secondary outcome [6] 0 0
Maximum Concentration (Cmax) of Forimtamig
Timepoint [6] 0 0
Up to 104 weeks
Secondary outcome [7] 0 0
Time of Maximum Concentration (Tmax) of Forimtamig
Timepoint [7] 0 0
Up to 104 weeks
Secondary outcome [8] 0 0
Minimum Concentration (Cmin) of Forimtamig
Timepoint [8] 0 0
Up to 104 weeks
Secondary outcome [9] 0 0
SC Bioavailability (F) of Forimtamig
Timepoint [9] 0 0
Up to 104 weeks
Secondary outcome [10] 0 0
Apparent Clearance (CL/F) of Forimtamig
Timepoint [10] 0 0
Up to 104 weeks
Secondary outcome [11] 0 0
Volume of Distribution at Steady State (Vss) of Forimtamig (IV only)
Timepoint [11] 0 0
Up to 104 weeks
Secondary outcome [12] 0 0
Area Under the Curve (AUC) at Various Time Intervals of Forimtamig
Timepoint [12] 0 0
Up to 104 weeks

Eligibility
Key inclusion criteria
* Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.
* Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator.
* Life expectancy of at least 12 weeks.
* Agreement to provide protocol-specific biopsy material.
* AEs from prior anti-cancer therapy resolved to Grade =<1.
* Measurable disease.
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.
* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to comply with protocol-mandated hospitalization and activities restrictions.
* Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after last dose of study drug.
* Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for MM treatment within 2 weeks before first forimtamig administration.
* Prior treatment with systemic immunotherapeutic agents within 2 weeks before first forimtamig administration.
* Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.
* Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first forimtamig administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed.
* Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.
* Prior solid organ transplantation.
* Active auto-immune disease or flare within 6 months prior to start of study treatment
* Any medical condition or abnormality in clinical laboratory tests that, in the Investigator's or Medical Monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.

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
11/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2026
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - North Melbourne
Recruitment postcode(s) [1] 0 0
3051 - North Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Gent
Country [2] 0 0
Denmark
State/province [2] 0 0
København Ø
Country [3] 0 0
Denmark
State/province [3] 0 0
Odense C
Country [4] 0 0
France
State/province [4] 0 0
Lille
Country [5] 0 0
France
State/province [5] 0 0
Nantes
Country [6] 0 0
France
State/province [6] 0 0
Pessac
Country [7] 0 0
Italy
State/province [7] 0 0
Campania
Country [8] 0 0
Italy
State/province [8] 0 0
Emilia-Romagna
Country [9] 0 0
Italy
State/province [9] 0 0
Lombardia
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
Spain
State/province [12] 0 0
Cantabria
Country [13] 0 0
Spain
State/province [13] 0 0
Navarra
Country [14] 0 0
Spain
State/province [14] 0 0
Salamanca
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Leeds
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BP42233 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
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)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04557150