Dose-Optimization/Expansion of SAR445877 in adults with advanced gastric or GEJ cancer
Official title: 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
Run by Sanofi · NCT07692204 · Data updated 2026-11-12
This phase 2 study tests SAR445877 as a single-drug treatment to see if it helps adults in China with advanced gastric or GEJ cancer after at least one prior therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | August 2, 2028 |
| Study ends | August 2, 2028 |
| Registry record updated | July 20, 2026 |
| Trial ID | NCT07692204 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with histologically or cytologically confirmed advanced unresectable or metastatic GC or Siewert type 2/3 GEJ cancer who have failed at least one prior therapy and meet local HER2 testing criteria.
✕Probably not a fit
Patients whose tumors do not respond to SAR445877 or who experience unacceptable toxicity may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, open-label study in approximately 30 Chinese adults with advanced unresectable or metastatic gastric cancer or Siewert type 2/3 gastroesophageal junction cancer. The trial uses a dose-optimization/expansion design to evaluate preliminary efficacy and safety of SAR445877 as monotherapy, enrolling patients who may have had limited benefit from prior treatments, including PD-1/PD-L1-based or other therapies depending on local standards. Eligible participants must have at least one measurable lesion by RECIST 1.1 and may require locally determined HER2 status, with HER2-positive cases eligible only if progression occurred after HER2-directed therapy. The study will randomize participants who relapsed after one prior regimen, to assess responses to SAR445877 in a setting where SOC is not favorable or not established.
Why it matters
Potential benefit: If successful, participants could experience tumor control and progression-free benefit from SAR445877 as a therapy alternative when standard options are limited.
How similar studies have gone: Preliminary signals in similar HER2-targeted or antibody-based approaches have shown activity in gastric/GEJ cancers, but this specific SAR445877 dose-optimization approach is novel in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 Siewert Type 2 \& 3 GEJ. * Participants with unknown HER2/neu status must have their HER2/neu status determined locally. Participants with HER2/neu negative are eligible. Participants with HER2/neu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible. 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 * Eastern Cooperative Oncology Group(ECOG)performance status of ≥2. * Predicted life expectancy ≤3 months. * Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment. * Active brain metastases or leptomeningeal metastases. * Known microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumor. * History of treatment-related immune-mediated (or immune-related) AEs from immune- modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity, or have not resolved to Grade ≤1. * Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine. * Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration. * Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related AEs (irAEs). * Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug. * Organ transplant requiring immunosuppressive treatment. * Uncontrolled or active infection with human immunodeficiency virus (HIV ), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency. 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.
Where it's running
-
Investigational Site Number : 1560001
Shanghai, China Recruiting
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.