LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.

Conditions

• Locally Advanced or Metastatic GC and GCJ Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• LM-302 — DRUG
  LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
• Apatinib — DRUG
  The subjects will receive Apatinib orally,qd
• Irinotecan — DRUG
  The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle

Study Details

This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy

Key Dates

Start date

Jun 24, 2024

Status verified

Feb 2026

Primary completion

Nov 10, 2026

Completion

Dec 15, 2026

Study Design

Enrollment

387 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LM-302
  Patients will accept LM-302 monotherapy
• Active Comparator: Physician's choice Apatinib or Irinotecan
  Patients will accept Apatinib or Irinotecan monotherapy

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: up to 42 months ]