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 cancer therapy being studied in adults with advanced solid tumors and in Chinese adults with advanced gastric or gastroesophageal junction cancer. It is being developed by Sanofi and is currently in Phase 2 development. It is not yet approved for any indication.
SAR445877 is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is running the clinical program for the drug, including a first-in-human solid tumor study and a dose optimization and expansion study in Chinese participants with gastric or gastroesophageal junction cancer.
SAR445877 is in Phase 2 development. A Phase 2 dose optimization and expansion study in Chinese adults with advanced gastric or gastroesophageal junction cancer is recruiting, and a Phase 1 first-in-human study in advanced solid tumors is also ongoing. The drug remains investigational and has not been approved by the FDA.
SAR445877 is being evaluated in two recruiting studies. NCT07692204 is a Phase 2 dose optimization and expansion study in adult Chinese participants with advanced gastric or gastroesophageal junction cancer, enrolling about 30 patients in China. NCT05584670 is a Phase 1 first-in-human dose escalation and expansion study in adults with advanced solid tumors across the United States, Chile, Israel, Japan, the Netherlands, and Spain, with planned enrollment of 542.
Yes, SAR445877 trials use biomarker-based patient selection. The Phase 2 study NCT07692204 in advanced gastric or gastroesophageal junction cancer and the Phase 1 study NCT05584670 in advanced solid tumors both enroll adults 18 years and older and select participants based on biomarker criteria rather than enrolling an unselected population.
SAR445877 is a small molecule therapeutic being developed by Sanofi for oncology. It is under study in advanced solid tumors and gastric or gastroesophageal junction cancer, with a Phase 1 first-in-human trial and a Phase 2 dose optimization and expansion trial currently recruiting participants.