NCT05191667

AN0025 and Chemoradiotherapy Combination in Esophageal Cancer

An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Chemoradiotherapy in Patients With Locally Advanced/Locally Recurrent Esophageal Cancer

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Adlai Nortye Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, phase Ib study to evaluate the safety, tolerability, and preliminary efficacy of AN0025 in combination with chemoradiotherapy (CRT) in patients with locally advanced/locally recurrent esophageal cancer.

Detailed description

This study will enroll patients with unresectable locally advanced/locally recurrent esophageal cancer or esophagogastric junction cancer to assess the safety and tolerability of AN0025 at 250mg QD and 500mg QD combined with concurrent chemoradiotherapy to fix the MTD or RP2D. At RP2D level, another 20 patients with unresectable locally advanced/locally recurrent esophageal cancer or esophagogastric junction cancer will be enrolled at PR2D dose level to explore the preliminary efficacy.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	AN0025	250 mg or 500 mg Q.D., oral administration

Timeline

• Start date: 2022-01-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-01-13
• Last updated: 2025-02-13

Locations

1 site across 1 country: China