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

Phase 3

Recruiting

• Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: ASKB589; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Placebo; Drug: Tislelizumab

• Registration Number: NCT06206733
• Lead Sponsor: AskGene Pharma, Inc.

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).

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.

Study Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-16
• Study Start: 2024-01-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25
• Primary Completion: 2026-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 780

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Placebo	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.
Group A	ASKB589	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.
Group A	Capecitabine	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.
Group A	Oxaliplatin	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.
Group B	Oxaliplatin	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.
Group A	Tislelizumab	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.
Group B	Tislelizumab	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.
Group B	Capecitabine	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	up to 18 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 Outcome Measures

Name	Time	Method
Overall Survival (OS)	up to 24 months	OS is defined as the time from the date of randomization until the date of death from any cause.

Trial Locations

Locations (1)

Beijing cancer hospital; 🇨🇳 Beijing, China