Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 2, open-label, dose optimization/expansion study to assess the preliminary efficacy and safety of SAR445877 as a monotherapy for Chinese participants aged at least 18 years with advanced Gastric Cancer(GC)/Gastroesophageal Junction cancer (GEJ). Participants with advanced GC/GEJ who relapsed to at least 1 prior regimen which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care, regardless combined positivity score (CPS) will be randomized in this study.
In this study, SAR445877 will be assessed as a monotherapy in approximately 30 participants with advanced unresectable or metastatic GC or Siewert Type 2 and 3 GEJ, and for whom receiving the standard of care (SOC) is not in his or her best interest, or where no SOC is established. Human epidermal growth factor receptor 2 (HER2) positive cases will not be eligible unless they have progressed on a HER2 targeted therapy. Those participants should have received at least 1 prior line of anti-cancer treatment which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care. Metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases are not eligible.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR445877 dose 1 | Experimental | Participants will receive SAR445877 through IV infusion |
|
| SAR445877 dose 2 | Experimental | Participants will receive SAR445877 through IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR445877 | Drug | Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 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 | From baseline to the end of study, up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| maximum serum concentration (Cmax) | Cycle 1 Day 1 to Day 14(Each cycle is 14 days) | |
| time to maximum concentration (tmax) | Cycle 1 Day 1 to Day 14(Each cycle is 14 days) | |
Not provided
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:
Prior anticancer therapy:
- Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1/PD-L1-based treatment or anti-Claudin 18.2 based treatment depending on local standard of care.
Measurable Disease:
- At least 1 measurable lesion per RECIST 1.1 criteria.
Exclusion Criteria:
Medical conditions
Note: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
Not provided
Not provided
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| area under the concentration-time curve over dosing interval (AUCtau) |
| Cycle 1 Day 1 to Day 14(Each cycle is 14 days) |
| End of infusion serum concentration (Cend of infusion) | at Cycle 1 Day 1and Cycle 3 Day 1(Each cycle is 14 days) |
| Percentage of participants with presence of anti-drug antibodies (ADA) against SAR445877 | From the first dose of Cycle 1 to 30 days after last dose of study interventions |
| Time to response (TTR) | Time to response (TTR), defined as the time from the first administration of investigational medicinal product (IMP) to the first documented evidence of confirmed partial response (PR) or complete response (CR) determined by Investigator per RECIST v1.1 | From baseline to the end of study, up to approximately 2 years |
| Duration of response (DOR) | Duration of response (DOR), defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) determined by Investigator per RECIST v1.1 or death from any cause, whichever occurs first | From baseline to the end of study, up to approximately 2 years |
| Clinical benefit rate | Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST v1.1 | From baseline to the end of study, up to approximately 2 years |
| Progression-free survival (PFS) | Progression-free survival (PFS), defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST v1.1 or death from any cause, whichever occurs first | From baseline to the end of study, up to approximately 2 years |
| Overall survival (OS) | Overall survival (OS), defined as the time from the first dose of IMP to the date of death due to any cause | From baseline to the end of study, up to approximately 2 years |
| Number of participants with presence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) | The time from the first dose of study interventions up to 30 days after last dose of study interventions |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |