Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR442085 · 1 trial · 1 indication
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 ...
SAR442085 is an investigational small molecule being studied for the treatment of relapsed or refractory multiple myeloma, a type of plasma cell myeloma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
SAR442085 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical trials for the treatment of relapsed or refractory multiple myeloma.
SAR442085 is in Phase 1 clinical development. A first-in-human study of the drug as a single agent in relapsed or refractory multiple myeloma has been completed. The drug is investigational and has not been approved for any use.
SAR442085 has one completed Phase 1 clinical trial, identified as NCT04000282, titled "First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma." The trial enrolled 37 participants and was conducted in the United States, Czechia, France, Greece, Spain, and Taiwan.
No alternative names for SAR442085 have been reported. The drug is identified solely by its code name SAR442085 in clinical trial records and is being developed by Sanofi for the treatment of relapsed or refractory multiple myeloma.