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 study identifier
interventional
30
1 country
1
Study Start
July 1, 2026
Actual (reported)Primary Completion
August 2, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2026
Actual (reported)July 1, 2026
Actual (reported)July 9, 2026
Actual (reported)August 2, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Participants will receive SAR445877 through IV infusion
Participants will receive SAR445877 through IV infusion
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Investigational Site Number : 1560001
Shanghai, 200131, China
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
First Submitted
June 24, 2026
First Posted
July 9, 2026
Study Start
July 1, 2026
Actual (reported)Primary Completion
August 2, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
August 2, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 20, 2026
Record last verified: 2026-07
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: