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

NCT06206733 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: ASK-LC-B589-III-1
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CLDN 18.2; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; ASKB589

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the time from the date of randomization until the date of radiological progressive disease (per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by Independent Review Committee (IRC)) or death from any cause, whichever is earliest.

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

Secondary Outcomes (1)

• Overall Survival (OS)

  Until death or withdrawal from the study

Other Outcomes (10)

• Objective Response Rate (ORR)

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

• Duration Of Response (DOR)

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

• Safety and tolerability assessed by adverse events (AEs)

  Until 90 days after the end of treatment

Study Arms (2)

Group A

EXPERIMENTAL

Treatment with intravenous infusion of ASKB589 on day 1 of each cycle. The infusion duration should be at least 3 hours, and can be shortened or extended in subsequent cycles as appropriate according to the patient's tolerability. Interruption or slow down of intravenous infusion is allowed to manage toxicity. Dosing is continued every cycle until participants meet the criteria of treatment discontinuation.

Drug: ASKB589; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab

Group B

PLACEBO COMPARATOR

Treatment with intravenous infusion of placebo on day 1 of each cycle. The infusion duration should be at least 3 hours, and can be shortened or extended in subsequent cycles as appropriate according to the patient's tolerability. Interruption or slow down of intravenous infusion is allowed to manage toxicity. Dosing is continued every cycle until participants meet the criteria for treatment discontinuation.

Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab; Drug: Placebo

Interventions

ASKB589 DRUG

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

Group A

Oxaliplatin DRUG

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

Group A; Group B

Capecitabine DRUG

Capecitabine will be administered orally twice daily (bid).

Group A; Group B

Tislelizumab DRUG

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

Group A; Group B

Placebo DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AskGene Pharma, Inc.: lead
• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing cancer hospital

Beijing, China

Location

MeSH Terms

Interventions

Oxaliplatin; Capecitabine; tislelizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 16, 2024
• Study Start: January 25, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)