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

NCT06206733 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2026-01-27

No results posted yet for this 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).

Conditions

  • Gastroesophageal Junction Adenocarcinoma
  • Gastric Adenocarcinoma

Interventions

DRUG

ASKB589

ASKB589 will be administered as a minimum 3-hour IV infusion

DRUG

Oxaliplatin

Oxaliplatin will be administered as a minimum 2-hour IV infusion

DRUG

Capecitabine

Capecitabine will be administered orally twice daily (bid).

DRUG

Tislelizumab

Tislelizumab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.

DRUG

Placebo

Placebo will be administered as a minimum 3-hour IV infusion

Sponsors & Collaborators

  • Jiangsu Aosaikang Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • AskGene Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-25
Primary Completion
2026-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206733 on ClinicalTrials.gov