Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma

Sponsor
Suzhou Transcenta Therapeutics Co., Ltd.
Study ID
NCT06093425
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab and either Capcecitabine + Oxaliplatin or Oxaliplatin+Leucovorin + 5-fluorouracil — DRUG
    TST001 will be administered i.v. Q3W along with standard prescribing dose of pembrolizumab Q3W + standard prescribed regimens for FOLFOX6 or CapOx.
  • Pembrolizumab and either Capcecitabine + Oxaliplatin or Oxaliplatin+Leucovorin + 5-fluorouracil — DRUG
    Placebo will be administered i.v. Q3W along with standard prescribing dose of pembrolizumab Q3W + standard prescribed regimens for FOLFOX6 or CapOx.

Study Details

Gastric/GEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric/GEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin 18.2 (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.

Key Dates

First listed
Oct 23, 2023
Start date
Jun 30, 2026
Status verified
Dec 2025
Primary completion
Oct 1, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
820 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TST001 + PDL-1 + Chemotherapy
    TST001 + Pembrolizumab + Chemotherapy (FOLFOX6 or CapOx)
  • Placebo Comparator: Placebo
    Placebo + Pembrolizumab + Chemotherapy (FOLFOX6 or CapOx)

Primary Outcome Measure

Progression free survival (PFS) based on RECIST (v1.1) [ Time Frame: Date of randomization until the date of documented progression or date of death due to any cause, whichever comes first up to 24 months after last dose. ]

Central Contacts

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