NCT05632939

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

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.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: AskGene Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-21
• Primary completion: 2025-10-31
• Completion: 2026-02-10
• First posted: 2022-12-01
• Last updated: 2025-09-10

Locations

1 site across 1 country: China