ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.

Last updated: September 3, 2025
Sponsor: AskGene Pharma, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

ASKB589 +CAPOX+Sintilimab/Tislelizumab

Clinical Study ID

NCT05632939
ASK-LC-B589- Ib/II
  • Ages > 18
  • All Genders

Study Summary

This was an open-label, phase 1/2 study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in combination with CAPOX and PD-1 inhibitors in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histopathologically confirmed unresectable locally advanced, recurrent, ormetastatic adenocarcinoma of the gastric and gastroesophageal junction currentlyineligible for surgery and radical radiotherapy.

  2. Investigators determined that the present situation of the patient justifieschemotherapy plus immunotherapy as first-line treatment.

  3. Tumor tissue samples are CLDN18.2 positive detected by central laboratory

  4. ECOG performance status 0-1.

  5. The results of the laboratory tests must meet all criteria

  6. Life expectancy of at least 3 months.

Exclusion

Exclusion Criteria:

  1. Known active central nervous system metastasis or suspected cancerous meningitis;

  2. There are moderate to large amounts of abdominal and pleural fluid.

  3. The presence of clinically uncontrollable third interspace fluid;

  4. Patients with any other malignant tumors within the past 5 years.

  5. Applicable to anti-HER-2 drug therapy;

  6. Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past;

  7. Patients have received antitumor therapy during the first 4 weeks before study druguse;

  8. Pregnant or lactating women; or women of childbearing age who have a positive bloodpregnancy test during screening period; or women of childbearing age and theirspouses who are unwilling to take effective contraceptive measures during the periodof this clinical trial and within 6 months after the end of the clinical trial;

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: ASKB589 +CAPOX+Sintilimab/Tislelizumab
Phase: 1/2
Study Start date:
February 21, 2023
Estimated Completion Date:
February 10, 2026

Study Description

A two-part, dose-escalation and expansion study of ASKB589 was initiated to determine the MTD, PK, PD, and efficacy in combination with chemotherapy and PD-1 inhibitors.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100089
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100089
    China

    Site Not Available

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