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

Phase 3Active Not RecruitingNCT06206733

AskGene Pharma, Inc.780 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

780

Conditions

Gastroesophageal Junction Adenocarcinoma Gastric Adenocarcinoma

Interventions

ASKB589DRUG

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

OxaliplatinDRUG

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

CapecitabineDRUG

Capecitabine will be administered orally twice daily (bid).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing cancer hospital

Beijing, China

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Overall Survival (OS)

OS is defined as the time from the date of randomization until the date of death from any cause.

Time frame: Until death or withdrawal from the study

Data from ClinicalTrials.gov

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