SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma
NCT07609667 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-05-27
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
Conditions
- Gastroesophageal Junction Adenocarcinoma
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 will be taken orally as the protocol described
Sponsors & Collaborators
-
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yi Ba, professor · Peking Union Medical College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-06-30
- Completion
- 2029-06-30
Countries
- China
Study Locations
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