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

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT07609667
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab — DRUG
    Tislelizumab will be administered as the protocol described
  • SKB315 for injection — DRUG
    Tislelizumab will be administered as the protocol described
  • Capecitabine — DRUG
    Capecitabine will be taken orally as the protocol described

Study Details

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

Key Dates

First listed
May 27, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SKB315+Tislelizumab
    SKB315+Tislelizumab
  • Experimental: SKB315+Tislelizumab+capecitabine
    SKB315+Tislelizumab+capecitabine

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 2 years ]

Central Contacts

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