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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion
Investigational Site Number : 1560001
Shanghai, China
RECRUITINGObjective 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
Time frame: From baseline to the end of study, up to approximately 2 years
maximum serum concentration (Cmax)
Time frame: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
time to maximum concentration (tmax)
Time frame: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
area under the concentration-time curve over dosing interval (AUCtau)
Time frame: Cycle 1 Day 1 to Day 14(Each cycle is 14 days)
End of infusion serum concentration (Cend of infusion)
Time frame: 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
Time frame: From the first dose of Cycle 1 to 30 days after last dose of study interventions
Time to response (TTR)
Time to response (TTR), defined as the time from the first administration of investigational medicinal product (IMP) to the first documented evidence of confirmed partial response (PR) or complete response (CR) determined by Investigator per RECIST v1.1
Time frame: From baseline to the end of study, up to approximately 2 years
Duration of response (DOR)
Duration of response (DOR), defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) determined by Investigator per RECIST v1.1 or death from any cause, whichever occurs first
Time frame: From baseline to the end of study, up to approximately 2 years
Clinical benefit rate
Clinical benefit rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST v1.1
Time frame: From baseline to the end of study, up to approximately 2 years
Progression-free survival (PFS)
Progression-free survival (PFS), defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST v1.1 or death from any cause, whichever occurs first
Time frame: From baseline to the end of study, up to approximately 2 years
Overall survival (OS)
Overall survival (OS), defined as the time from the first dose of IMP to the date of death due to any cause
Time frame: From baseline to the end of study, up to approximately 2 years
Number of participants with presence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
Time frame: The time from the first dose of study interventions up to 30 days after last dose of study interventions
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