NCT06587425

The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Detailed description

The antibody-drug conjugate (ADC) targeting CLDN18.2 exerts its anti-tumor effects through multiple mechanisms, including direct cytotoxicity to CLDN18.2-positive tumor cells via the delivery of a potent small-molecule toxin, a bystander effect that induces cytotoxicity in adjacent CLDN18.2-negative tumor cells, and the activation of the immune system through antibody-dependent cellular cytotoxicity (ADCC). The combination of this ADC with immune checkpoint inhibitors holds potential for synergistic anti-tumor activity. LM-302, an ADC specifically targeting CLDN18.2 and comprising a monoclonal antibody conjugated to MMAE, has demonstrated favorable efficacy and safety profiles in both preclinical and clinical studies for CLDN18.2-expressing gastrointestinal malignancies, including gastric and gastroesophageal junction adenocarcinomas. The combination of LM-302 with immune checkpoint inhibitors may offer enhanced clinical benefits for patients with advanced gastric cancer. This clinical study aims to evaluate the efficacy and safety of LM-302 (ADC targeting Claudin18.2) in combination with cadonilimab (a bispecific antibody targeting PD-1 and CTLA-4) and capecitabine as a first-line treatment in patients with unresectable, recurrent, or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma.

Conditions

• Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	LM-302+Candonilimab+Capecitabine	LM-302: 1.8mg/kg ivgtt d1, q2w; Canonilimab: 6mg/kg ivgtt d1, q2w; Capecitabine: 1000mg/m\^2 po bid d1-10, q2w.

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-07-31
• Completion: 2026-12-31
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China