ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.

NCT ID: NCT05632939

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2026-02-10

Brief Summary

This was an open-label, phase 1/2 study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in combination with CAPOX and PD-1 inhibitors in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.

Detailed Description

A two-part, dose-escalation and expansion study of ASKB589 was initiated to determine the MTD, PK, PD, and efficacy in combination with chemotherapy and PD-1 inhibitors.

Conditions

Gastric Cancer; Gastroesophageal Cancer (GC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASKB589 +CAPOX+Sintilimab/Tislelizumab

Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 6 cycles; Capecitabine: oral administration, 1000mg/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Sintilimab/Tislelizumab was administered intravenously at 200mg. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years.

ASKB589 is administered intravenously at a fixed dose. the drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.

Group Type: EXPERIMENTAL

ASKB589 +CAPOX+Sintilimab/Tislelizumab

Intervention Type: DRUG

Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 6 cycles; Capecitabine: oral administration, 1000mg/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Sintilimab/Tislelizumab was administered intravenously at 200mg. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years.

ASKB589 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.

Interventions

ASKB589 +CAPOX+Sintilimab/Tislelizumab

Oxaliplatin: intravenous infusion, 130mg/m2, infusion for more than 3h, every 3 weeks for a cycle, infusion 6 cycles; Capecitabine: oral administration, 1000mg/m2, 2 times, 14 days, 7 days rest, every 3 weeks for a cycle; Sintilimab/Tislelizumab was administered intravenously at 200mg. The drug was administered once every 3 weeks, and the longest cumulative duration was 2 years.

ASKB589 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle, with the longest cumulative duration of 2 years.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy.

2. Investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment.

3. Tumor tissue samples are CLDN18.2 positive detected by central laboratory

4. ECOG performance status 0-1.

5. The results of the laboratory tests must meet all criteria

6. Life expectancy of at least 3 months.

Exclusion Criteria

1. Known active central nervous system metastasis or suspected cancerous meningitis;

2. There are moderate to large amounts of abdominal and pleural fluid.

3. The presence of clinically uncontrollable third interspace fluid；

4. Patients with any other malignant tumors within the past 5 years.

5. Applicable to anti-HER-2 drug therapy；

6. Anti-CLDN18.2 antibody, anti-PD-1 antibody, or drug therapy at any time in the past；

7. Patients have received antitumor therapy during the first 4 weeks before study drug use;

8. Pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;

• 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, Beijing Municipality, China

Countries

China

Other Identifiers

ASK-LC-B589- Ib/II

Identifier Type: -

Identifier Source: org_study_id