Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04000282 | First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma | PHASE1 | COMPLETED | 37 | — | — | Aug 19, 2019 | Sep 4, 2023 | Sep 12, 2025 | 12 | United States, Czechia +4 |
MTD is defined as the dose level with highest probability of investigational medicinal product (IMP) related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (\>33%)
RP2D is defined as the dose selected for the further single agent testing - including in Phase 1 expansion part B.
Overall response rate (ORR): is defined as the proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), using the International Myeloma Working Group (IMWG) criteria.
| Arm | Type | Description |
|---|---|---|
| Part A: SAR442085 dose escalation | EXPERIMENTAL | SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration. |
| Part B: SAR442085 dose expansion | EXPERIMENTAL | SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration. |
| Name | Type | Description |
|---|---|---|
| SAR442085 | DRUG | Pharmaceutical form:Sterile lyophilized powder for reconstitution for infusion Route of administration: intravenous |
Inclusion criteria : * Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is \>18 years old, at the time of signing the informed consent. * Participant has given voluntary written informed consent. * Participant has been previousy diagnosed with ...