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

NCT07692204 | Recruiting Phase 2

• 1 other identifier: TCD23644
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oesophageal Carcinoma; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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)

• 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

Study Arms (2)

SAR445877 dose 1

EXPERIMENTAL

Participants will receive SAR445877 through IV infusion

Drug: SAR445877

SAR445877 dose 2

EXPERIMENTAL

Participants will receive SAR445877 through IV infusion

Drug: SAR445877

Interventions

SAR445877 DRUG

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

SAR445877 dose 1; SAR445877 dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number : 1560001

Shanghai, 200131, China

RECRUITING

Related Links

• TCD23644 Plain Language Results Summary

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 2, 2028
• Study Completion (Estimated): August 2, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)