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

StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Sponsor changed: Suzhou Transcenta Therapeutics Co., Ltd. to Transcenta Therapeutics (Hangzhou) Co., Ltd.
    • Start date: Jun 30, 2026 to Jun 30, 2027
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 6 entries
  2. Primary completion date: Oct 1, 2025 to Oct 1, 2029v2 Show 9 more changesShow less
    • Start date: Oct 31, 2023 to Jun 30, 2026
    • Primary endpoint revised
    • Enrollment target: 950 to 820
    • Study completion date: Jan 31, 2026 to Jan 31, 2030
    • Interventions: Placebo CapOx or mFOLFOX6 and NIVO or (Substudy) Placebo, Oxaliplatin and capecitabine or 5-fluorouracil (5-FU) (Drug), TST001, CapOx or… to Pembrolizumab and either Capcecitabine + Oxaliplatin or Oxaliplatin+Leucovorin + 5-fluorouracil (Drug), Pembrolizumab and either…
    • Eligibility criteria shortened, about 196 words
    • Secondary endpoints revised (6)
    • Study description revised
    • Study title expanded, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06093425
Lead Sponsor Transcenta Therapeutics (Hangzhou) Co., Ltd.
Conditions
(from sponsor)		 Gastric Cancer, Gastroesophageal-junction Cancer, Advanced Cancer
Related terms Stomach Neoplasms
Enrollment 820 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov