Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR446523 · 1 trial · 1 indication
The incidence of DLTs will be evaluated using NCI CTCAE version 5.0 criteria.
ORR is defined as the proportion of participants with sCR, CR, VGPR, and PR assessed as per Investigator according to the 2016 IMWG response criteria.
| Arm | Type | Description |
|---|---|---|
| Part A (Dose escalation) | EXPERIMENTAL | Participants will receive SAR446523 |
| Part B Dose-1 (Dose optimization) | EXPERIMENTAL | Participants will receive SAR446523 Dose-1 |
| Part B Dose-2 (Dose optimization) | EXPERIMENTAL | Participants will receive SAR446523 Dose-2 |
| Name | Type | Description |
|---|---|---|
| SAR446523 | DRUG | Pharmaceutical form: Powder for solution for injection; Route of administration: Subcutaneous (SC) |
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 (Par...
SAR446523 is an investigational small molecule being developed for the treatment of relapsed or refractory plasma cell myeloma. It is administered by subcutaneous injection and is currently being studied in adult participants with this condition.
SAR446523 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 1 clinical development.
SAR446523 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied in clinical trials.
SAR446523 is being studied in a Phase 1 clinical trial with the identifier NCT06630806. This trial is investigating the safety and efficacy of the drug when injected subcutaneously in adult participants with relapsed or refractory myeloma. The trial is currently recruiting participants.
SAR446523 is administered by subcutaneous injection. This route of administration is being evaluated in the ongoing Phase 1 clinical trial for the treatment of relapsed or refractory plasma cell myeloma.
Yes, the Phase 1 clinical trial of SAR446523 is randomized and controlled. The trial is not double-blind, and it is designed to evaluate the safety and efficacy of the drug in adult participants with relapsed or refractory myeloma.