JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.

Recruiting Phase 3 Interventional Study
Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
560 (estimated)
Sponsor
Shanghai Junshi Bioscience Co., Ltd. · Other
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About This Trial
This is a multicenter, randomized, controlled, open-label, Phase III study, designed to evaluate the efficacy and safety of JS107 versus investigator-selected therapy in the second-line or later treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2. The study population consists of patients with CLDN18.2-positive, HER2-negative, locally adva…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate in this study, have ICF signed after sufficient informed consent, and have good compliance. 2. Age ≥ 18 years, male or female. 3. ECOG PS 0 or 1. 4. Expected survival period≥ 3 months. 5. Patients with HER2 negative G/GEJ adenocarcinoma confirmed by hi…
Contacts

Yongdong Zhang

18042483763

yongdong_zhang@junshipharma.com

CONTACT