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.
Treatment: SAR445877 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
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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