Status and phase
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About
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
Full description
The duration of the study for a participant will include A screening period: up to 28 days prior day 1 of cycle 1 (C1D1) A treatment period: enrolled participants will receive administration of 4 weeks cycles of SAR445514 subcutaneously.
The End of treatment visit will occur 30 days (+/- 7 days) from last investigational medicinal product (IMP) administration or prior initiation of further therapy, whichever comes first.
The follow-up period will continue until death, participant's request to discontinue study, final Overall Survival analysis or upon cancellation of survival follow-up at the discretion of the Sponsor at any timepoint.
Enrollment
Sex
Ages
Volunteers
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 RR LCA (Part 1b and 3b) must have received at least 1 prior line of treatment comprising at least 1 proteasome inhibitor.
For dose escalation, body weight within 40 to 120 kg
Capable of giving signed informed consent
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
Participants with RRMM (Part 1a, 2, and 3a)
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:
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
Prior/concomitant therapy
Prior/concurrent clinical study experience
Diagnostic assessments
Other exclusions
Primary purpose
Allocation
Interventional model
Masking
111 participants in 6 patient groups
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Central trial contact
Trial Transparency email recommended (Toll free for US & Canada)
Data sourced from clinicaltrials.gov
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