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

A Phase III Study Evaluating the Efficacy and Safety of ASKB589 Combined With CAPOX and PD-1 Inhibitor as First-Line Treatment in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06206733

Enrollment

780

Registered

2024-01-16

Start date

2024-01-25

Completion date

2028-12-30

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Keywords

CLDN 18.2, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, ASKB589

Brief summary

Detailed 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.

Interventions

DRUGASKB589

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

DRUGOxaliplatin

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

DRUGCapecitabine

Capecitabine will be administered orally twice daily (bid).

DRUGTislelizumab

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically confirmed adenocarcinoma of gastric and gastroesophageal junction 2. Advanced recurrent or metastatic disease confirmed by imaging within 28 days prior to 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 site investigator within 28 days prior to randomization 6. CLDN 18.2 positive

Exclusion criteria

1. Patients with active central nervous system (CNS) metastases or suspected carcinomatous 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

Design outcomes

Primary

Measure	Time frame	Description
Progression Free Survival (PFS)	Until disease progression or withdrawal from the study (generally up to 24 months)	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.

Secondary

Measure	Time frame	Description
Overall Survival (OS)	Until death or withdrawal from the study	OS is defined as the time from the date of randomization until the date of death from any cause.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026