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ACTIVE NOT RECRUITING
NCT05632939
PHASE1/PHASE2

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

Sponsor: AskGene Pharma, Inc.

View on ClinicalTrials.gov

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.

Official title: A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable Gastric/Esophagogastric Junction Cancer.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2023-02-21

Completion Date

2026-02-10

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China