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

Conditions

• Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• JS107 for Injection — DRUG
  Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
• Irinotecan — DRUG
  Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
• Paclitaxel — DRUG
  Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
• Docetaxel — DRUG
  Subjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).

Study Details

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 advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy. The primary endpoints of the study are BICR-assessed progression-free survival and overall survival. Number of subjects and allocation:This study plans to enroll approximately 560 subjects, who will be randomized in a 1:1 ratio to receive either JS107 (experimental group) or investigator-selected therapy (control group).

Key Dates

Start date

Dec 24, 2025

Status verified

Jan 2026

Primary completion

Oct 13, 2027

Completion

Oct 17, 2028

Study Design

Enrollment

560 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental group
  JS107: 3mg/kg, intravenous infusion, on Day 1, with a treatment cycle of every 21 days.
• Active Comparator: Control group
  Including 3 treatment regimens: irinotecan, paclitaxel, and docetaxel. investigators will select one regimen based on the patient's previous treatment medications, clinical benefits, and tolerability, and the administration will follow clinical guidelines and/or clinical practices. In addition, before administration, corresponding premedications (including antiemetics, preventive anti-allergy drugs, etc.) can be given with reference to clinical guidelines or drug instructions. Irinotecan: 150mg/m², intravenous infusion, on days 1 and 15, with a 28-day treatment cycle. Paclitaxel: 80mg/m², intravenous infusion, on days 1, 8, and 15, with a 28-day treatment cycle. Docetaxel: 75mg/m², intravenous infusion, on day 1, with a 21-day treatment cycle.

Primary Outcome Measure

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

Central Contacts

• Yongdong Zhang
  18042483763
  [email protected]