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

NCT ID: NCT06206733

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2028-12-30

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.

Conditions

Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

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 Type: EXPERIMENTAL

ASKB589

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

Capecitabine will be administered orally twice daily (bid).

Tislelizumab

Intervention Type: DRUG

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

Group B

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 Type: PLACEBO_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

Capecitabine will be administered orally twice daily (bid).

Tislelizumab

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

ASKB589

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Capecitabine

Capecitabine will be administered orally twice daily (bid).

Intervention Type: DRUG

Tislelizumab

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Aosaikang Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

AskGene Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing cancer hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuan Yangzhou

Role: CONTACT

yuanyangzhou@ask-pharm.com

025-8509062

Han Dong

Role: CONTACT

handong@ask-pharm.com

025-8509062

Facility Contacts

Shen Lin

Role: primary

doctorshenlin@sina.cn

Other Identifiers

ASK-LC-B589-III-1

Identifier Type: -

Identifier Source: org_study_id