RecruitingPhase 2NCT07692204

A Dose Optimization/Expansion Study of SAR445877 in Adult Chinese Participants With Advanced Gastric or Gastroesophageal Junction Cancer

A Phase 2, Open-label, Dose Optimization/Expansion Study of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Gastric or Gastroesophageal Junction Cancer


Sponsor

Sanofi

Enrollment

30 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SAR445877 for people with gastric cancer and oesophageal carcinoma. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSAR445877

Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion


Locations(1)

Investigational Site Number : 1560001

Shanghai, China

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NCT07692204


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