Active — Not RecruitingPhase 3

ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma

China780 participantsStarted 2024-01-25

Plain-language summary

This study is a multicenter, randomized, double-blind, standard-of-care controlled phase III clinical study conducted in China. The purpose of this study is to evaluate the efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically confirmed adenocarcinoma of gastric and gastroesophageal junction
✓. Advanced recurrent or metastatic disease confirmed by imaging within 28 days prior to randomization
✓. Suitable for chemotherapy combined with PD-1 inhibitor
✓. Not suitable for anti-HER2 therapy
✓. Have at least one measurable lesion according to RECIST1.1 assessed by site investigator within 28 days prior to randomization
✓. CLDN 18.2 positive

Exclusion criteria

✕. Patients with active central nervous system (CNS) metastases or suspected carcinomatous meningitis
✕. Participants have significant gastric bleeding
✕. The presence of clinically uncontrollable third interspace fluid
✕. Received anti-CLDN18.2 antibody at any time in the past
✕. Suspected complete or partial obstruction of gastroesophageal access

What they're measuring

Progression Free Survival (PFS)

Timeframe: Until disease progression or withdrawal from the study (generally up to 24 months)

Trial details

NCT IDNCT06206733

SponsorAskGene Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Gastroesophageal Junction Adenocarcinoma trials