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OncoMatch/Clinical Trials/NCT07692204

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

Is NCT07692204 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies SAR445877 for gastric cancer.

Phase 2RecruitingSanofiNCT07692204Data as of Sep 2026Location: China

Treatment: SAR445877This 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.

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Extracted eligibility criteria

Treatments studied

Other

SAR445877

Cancer type

Gastric Cancer

Esophageal Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) wild-type

Participants with HER2/neu negative are eligible

Excluded: MSI high

Known microsatellite instability-high (MSI-H) ... tumor

Excluded: MLH1 loss

mismatch repair-deficient (dMMR) tumor

Excluded: MSH2 loss

mismatch repair-deficient (dMMR) tumor

Excluded: MSH6 loss

mismatch repair-deficient (dMMR) tumor

Excluded: PMS2 loss

mismatch repair-deficient (dMMR) tumor

Allowed: HER2 (ERBB2) overexpression

Participants with HER2/neu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic anticancer therapy

Participants should have failed or relapsed after at least 1 prior line of treatment

Lab requirements

Cardiac function

Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration

Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07692204 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received systemic anticancer therapy.

Does this trial require ERBB2?

Yes, ERBB2 wild-type is a required biomarker for enrollment.

Are patients with MSI alterations eligible?

No. MSI high is an exclusion criterion.

Are patients with MLH1 alterations eligible?

No. MLH1 loss is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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