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Trial Title:
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
NCT ID:
NCT06630806
Condition:
Plasma Cell Myeloma Refractory
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
anti-GPRC5D NK cell targeting therapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Study is non-randomized for part A but randomized for part B. Study drug will be assigned
in sequential manner in Part A but parallel assignment in Part B.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SAR446523
Description:
Pharmaceutical form: Powder for solution for injection; Route of administration:
Subcutaneous (SC)
Arm group label:
Part A (Dose escalation)
Arm group label:
Part B Dose-1 (Dose optimization)
Arm group label:
Part B Dose-2 (Dose optimization)
Summary:
This is a first-in-human study of SAR446523 conducted in patients with RRMM.
The study consists of two parts:
Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be
explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD),
and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose
optimization part.
Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1
ratio using interactive response technology (IRT) to either one of the chosen dose
regimens of SAR446523 (determined from data coming from Part A), to determine the optimal
dose as the recommended phase 2 dose (RP2D) of SAR446523.
Detailed description:
The study will be considered ongoing until the last participant last visit has occurred.
Participants will be allowed to continue therapy until disease progression, unacceptable
AEs, participant or Investigator's request to discontinue treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants with a documented diagnosis of multiple myeloma (MM) with measurable
disease.
- Contraceptive use by men and women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Dose escalation (Part A) -Participants must have received at least 3 prior lines of
antimyeloma therapy which must include a second or third generation immunomodulator,
proteosome inhibitor (PI), and anti CD38 monoclonal antibody (mAb) administered with the
same or different line.
AND
- Must be either relapsed or refractory to the above therapies, or are intolerant to
them, based up on the Investigator's judgment.
- Note: In Part A, prior exposure to anti g-protein-coupled receptor, class c, group
5, member d (GPRC5D) therapy and anti B-cell maturation antigen (BCMA) therapy is
allowed.
Dose optimization (Part B)
- Participants must have received at least 3 prior lines of antimyeloma therapy which
must include a second or third generation immunomodulator, PI, anti-CD38 mAb, and
anti-B Cell Maturation Antigen (anti-BCMA) agent. AND
- Must be either relapsed or refractory to the above therapies, or are intolerant to
them, based up on the Investigator's judgment.
- Note: In Part B, prior exposure to antiGPRC5D therapy is not allowed.
Exclusion Criteria:
-Participants are excluded from the study if any of the following criteria apply: Eastern
cooperative oncology group performance status (ECOG PS) of 2 or greater.
- Primary systemic and localized amyloid light chain (AL) amyloidosis, active
polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes
(POEMS) syndrome, active plasma cell leukemia.
- Systemic antimyeloma treatment within 14 days before the first study treatment
administration.
- Prior treatment with natural killer (NK)-cell engaging therapy (such as monoclonal
antibody with antibody-dependent cellular cytotoxicity as primary mechanism of
action) within 90 days of the first study treatment administration.
- Inadequate organ and marrow function.
- Participants with significant concomitant illness.
The above information is not intended to contain all considerations relevant to the
potential participation in a clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Investigational Site Number : 0360001
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Status:
Recruiting
Start date:
October 30, 2024
Completion date:
May 14, 2029
Lead sponsor:
Agency:
Sanofi
Agency class:
Industry
Source:
Sanofi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06630806
