Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR439459 · 1 trial · 1 indication
Incidence of DLTs at Cycle 1 and/or 2 in Parts 1A and 1B.
Efficacy as documented by ORR will be assessed by evaluation of antitumor response information according to RECIST 1.1 (Part 2B).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation SAR439459 monotherapy | EXPERIMENTAL | SAR439459 administered intravenously every 2 weeks in a 14-day cycle with escalating doses |
| Dose Expansion SAR439459 monotherapy | EXPERIMENTAL | SAR439459 administered intravenously every 3 weeks in a 21-day cycle with the previously determined recommended doses as the patients will be randomized to 2 different doses |
| Dose Escalation SAR439459 + cemiplimab combination | EXPERIMENTAL | SAR439459 + cemiplimab combination administered intravenously every 2 weeks in a 14-day cycle or every 3 weeks in a 21-day cycle with escalating SAR439459 doses and cemiplimab |
| Dose Expansion SAR439459 + cemiplimab combination | EXPERIMENTAL | SAR439459 + cemiplimab combination administered intravenously every 3 weeks in a 21-day cycle with previously determined SAR439459 doses and cemiplimab |
| Name | Type | Description |
|---|---|---|
| SAR439459 | BIOLOGICAL | Pharmaceutical form: powder for solution for infusion Route of administration: intravenous infusion |
| Cemiplimab REGN2810 | DRUG | Pharmaceutical form: solution for infusion Route of administration: intravenous infusion |
Inclusion criteria: Dose escalation (Part 1A and Part 1B) * Patients with histologically confirmed, advanced unresectable or metastatic solid tumor whom in the opinion of the Investigator does not have a suitable alternative therapy. Dose expansion (Part 2A) * Patients with histologically confir...
SAR439459 is an investigational monoclonal antibody being studied for the treatment of malignant solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.
SAR439459 targets TGFb, a protein involved in tumor growth and immune regulation. By binding to TGFb, the antibody is designed to modulate its activity, which may have anti-tumor effects. This mechanism is being evaluated in the context of advanced solid tumors.
SAR439459 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with malignant solid tumors.
SAR439459 is in Phase 1 clinical development. This early-stage trial is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of the drug. It is an investigational agent and has not yet received regulatory approval for any indication.
SAR439459 has been studied in a Phase 1 clinical trial registered as NCT03192345. This first-in-human study evaluated SAR439459 as a monotherapy and in combination with cemiplimab in patients with advanced solid tumors. The trial was completed and enrolled 161 participants across multiple countries.
SAR439459 is a distinct investigational monoclonal antibody developed by Sanofi. It is being studied alone and in combination with cemiplimab, which is a separate PD-1 inhibitor. No alternative names for SAR439459 have been reported in the clinical trial information.