NCT06321913

Study of IBI343 in Subjects With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Phase II Study to Evaluate the Safety, Tolerability and Efficacy of IBI343 Combined With Sintilimab in Subjects With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial\] is toevaluate the safety, tolerability and efficacy of IBI343 combined with sintilimab in the treatment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma. The main aim is to evaluate the efficacy and safety of IBI343 combination treatment in subjects with advanced gastric/gastroesophageal junction adenocarcinoma.The secondary aim is to evaluate other efficacy endpoints in subjects with IBI343 combination therapy for advanced gastric/gastroesophageal junction adenocarcinoma.The exploratory purpose is to evaluate the correlation between CLDN18.2 expression levels in tumor tissues and the efficacy of IBI343 combination therapy. Participants will be asked to enroll about 3-12 patients in the safety introduction period.，and about 25 patients are planned to be enrolled in the POC phase.

Detailed description

The goal of this clinical trial\] is toevaluate the safety, tolerability and efficacy of IBI343 combined with sintilimab in the treatment of subjects with advanced gastric/gastroesophageal junction adenocarcinoma. The main aim is to evaluate the efficacy and safety of IBI343 combination treatment in subjects with advanced gastric/gastroesophageal junction adenocarcinoma.The secondary aim is to evaluate other efficacy endpoints in subjects with IBI343 combination therapy for advanced gastric/gastroesophageal junction adenocarcinoma. Participants will be asked to enroll about 3-12 patients in the safety introduction period.，and about 25 patients are planned to be enrolled in the POC phase.

Conditions

• Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	IBI343 combined with IBI308	IBI343 Specifications: 100 mg/bottle Approval method: TBD Q3W intravenous infusion (IV) sintilimab Specifications: 100mg (10ml)/bottle Afghan way: 200 mg Q3W IV infusion

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-03-20
• Last updated: 2024-03-20