Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR445877 · 2 trials · 3 indications
Objective response rate, which is defined as the proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
DLTs will be defined using NCI CTCAE version 5.0 or ASTCT criteria for CRS or immune effector cell-associated neurotoxicity syndrome (ICANS)
Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response (BOR) determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
| Arm | Type | Description |
|---|---|---|
| SAR445877 dose 1 | EXPERIMENTAL | Participants will receive SAR445877 through IV infusion |
| SAR445877 dose 2 | EXPERIMENTAL | Participants will receive SAR445877 through IV infusion |
| SAR445877 Escalation Phase (Part 1A) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously in participants with solid tumors over a 14-day cycle. |
| SAR445877 Escalation Phase (Part1B) | EXPERIMENTAL | SAR445877 will be administered intravenously in combination with ADG126 in participants with advanced unresectable or metastatic melanoma, non-small cell lung cancer (NSCLC); renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), colorectal cancer (MSIH/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). |
| SAR445877 Escalation Phase (Part 1C) | EXPERIMENTAL | SAR445877 will be administered intravenously in combination with bevacizumab in participants with metastatic colorectal cancer (CRC). |
| SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC). |
| SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC). |
| SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously in participants with hepatocellular carcinoma (HCC). |
| SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ). |
| SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ). |
| SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously IV in participants with immune infiltrated tumor type. |
| SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2B) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC). |
| SAR445877 Expansion/optimization Phase: Cohort E2 (Part 2A) | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC). |
| SAR445877 Expansion/optimization Phase: Cohort E3 (Part 2B) | EXPERIMENTAL | SAR445877 will be administered intravenously in combination with cetuximab in participants with colorectal cancer. |
| SAR445877 Japan Cohort F | EXPERIMENTAL | SAR445877 monotherapy will be administered intravenously in participants with advanced unresectable or metastatic solid tumor, from Japan. |
| SAR445877 Expansion/Optimization Phase Cohort G1 (Part 2C) | EXPERIMENTAL | SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma. |
| SAR445877 Expansion/Optimization Phase Cohort G2 (Part 2C) | EXPERIMENTAL | SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma. |
| SAR445877 Expansion/Optimization Phase Cohort G3 (Part 2C) | EXPERIMENTAL | The Standard of Care (nivolumab and ipilimumab) will be administered intravenously in participants with metastatic melanoma. |
| SAR445877 Expansion/Optimization Phase Cohort H1 (Part 2D) | EXPERIMENTAL | SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC. |
| SAR445877 Expansion/Optimization Phase Cohort H2 (Part 2D) | EXPERIMENTAL | SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC. |
| Name | Type | Description |
|---|---|---|
| SAR445877 | DRUG | Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion |
| Cetuximab | DRUG | Solution for infusion |
| ADG126 | DRUG | Solution for infusion |
| Bevacizumab | DRUG | Solution for infusion |
| Nivolumab | DRUG | Solution for infusion |
| Ipilimumab | DRUG | Solution for infusion |
Inclusion Criteria: Age \- Participant must be at least 18 years of age inclusive (or country's legal age of majority if \>18 years), at the time of signing the informed consent. Cancer diagnosis: * Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or ...
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SAR445877 is an investigational small molecule being developed by Sanofi for the treatment of advanced solid tumors, including gastric cancer and gastroesophageal junction cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
SAR445877 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is in Phase 2 clinical trials for oncology indications, specifically advanced solid tumors and gastric cancer.
SAR445877 is currently in Phase 2 clinical development. It is being studied in a dose optimization and expansion trial in Chinese patients with advanced gastric or gastroesophageal junction cancer, following an earlier Phase 1 first-in-human study in advanced solid tumors.
SAR445877 is being evaluated in two clinical trials. The first is NCT05584670, a Phase 1 dose escalation and expansion study in adults with advanced solid tumors, recruiting in the US, Chile, Israel, Japan, Netherlands, and Spain. The second is NCT07692204, a Phase 2 dose optimization study in Chinese adults with advanced gastric or gastroesophageal junction cancer.
SAR445877 is not FDA approved. It is an investigational drug currently in clinical development, with active trials in Phase 1 and Phase 2. No approval status has been granted, and it remains under study for safety and efficacy in oncology indications.