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

Last updated: January 26, 2026
Sponsor: AskGene Pharma, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Gastric Ulcers

Stomach Cancer

Digestive System Neoplasms

Treatment

Placebo

Oxaliplatin

ASKB589

Clinical Study ID

NCT06206733
ASK-LC-B589-III-1
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of gastric and gastroesophageal junction

  2. Advanced recurrent or metastatic disease confirmed by imaging within 28 days priorto randomization

  3. Suitable for chemotherapy combined with PD-1 inhibitor

  4. Not suitable for anti-HER2 therapy

  5. Have at least one measurable lesion according to RECIST1.1 assessed by siteinvestigator within 28 days prior to randomization

  6. CLDN 18.2 positive

Exclusion

Exclusion Criteria:

  1. Patients with active central nervous system (CNS) metastases or suspectedcarcinomatous meningitis

  2. Participants have significant gastric bleeding

  3. The presence of clinically uncontrollable third interspace fluid

  4. Received anti-CLDN18.2 antibody at any time in the past

  5. Suspected complete or partial obstruction of gastroesophageal access

Study Design

Total Participants: 780
Treatment Group(s): 5
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 25, 2024
Estimated Completion Date:
December 30, 2028

Study Description

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).

This study will also evaluate efficacy, physical function, safety, and tolerability of ASKB589, as well as its effects on quality of life. Pharmacokinetics (PK) of ASKB589 and the immunogenicity profile of ASKB589 will be evaluated as well.

Connect with a study center

  • Beijing cancer hospital

    Beijing,
    China

    Site Not Available

  • Beijing cancer hospital

    Beijing 1816670,
    China

    Site Not Available

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