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NOT YET RECRUITING
NCT07609667
PHASE2

SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Official title: A Phase II Study Evaluating the Efficacy and Safety of SKB315 Combination Therapy in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-06-30

Completion Date

2029-06-30

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

Tislelizumab will be administered as the protocol described

DRUG

SKB315 for injection

Tislelizumab will be administered as the protocol described

DRUG

Capecitabine

Capecitabine will be taken orally as the protocol described

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China