JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor
NingBo Junyan Hongshi Biosciences Co., Ltd
Study ID
NCT07584135
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Gastric Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Injection JS107&Toripalimab& Oxaliplatin Injection& Capecitabine — DRUG
    JS107: 2 mg/kg on day 1 Q3W; Toripalimab (T): 240 mg on day 1 Q3W. Capecitabine (C): 750 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 100mg/m² on Day1 Q3W, Maximum of 6 cycles.
  • Sintilimab& Oxaliplatin Injection& Capecitabine — DRUG
    Sintilimab: 3 mg/kg or 200 mg Day1 Q3W, Capecitabine: 1000 mg/m² BID Day1-Day14, Q3W，Oxaliplatin 130mg/m² on Day1 Q3W, Maximum of 6 cycles.

Study Details

This study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G/GEJ adenocarcinoma. The research subjects were patients with unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma who were CLDN18.2-positive and HER2-negative and had not received systemic treatment before (except for neoadjuvant/adjuvant therapy that occurred more than 6 months after disease progression/recurrence from the last treatment). The study took BICR-PFS and OS as Dual primary endpoints.

Key Dates

First listed
May 13, 2026
Start date
May 28, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: JS107 in combination with Toripalimab and XELOX Chemotherapy
  • Active Comparator: Sintilimab in combination with XELOX Chemotherapy

Primary Outcome Measure

BICR-PFS [ Time Frame: up to 2 years ]

Central Contacts

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