NCT04975958

Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors

An Open-Label, Multicenter, Phase 1a Study of AN2025 and AN0025 in Double Combination With Atezolizumab and in Triple Combination With Atezolizumab in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Adlai Nortye Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors.

Detailed description

This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors. This study consists of three DLT Observation Periods I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. In all three Observation Periods, a "6 + 3 design" will be utilized for dose finding with dose escalation and de-escalation.

Conditions

• Locally Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	AN2025	oral administration
DRUG	AN0025	oral administration
DRUG	Atezolizumab 1200 mg in 20 ML Injection	infusion

Timeline

• Start date: 2021-09-07
• Primary completion: 2025-01-24
• Completion: 2025-01-24
• First posted: 2021-07-26
• Last updated: 2025-06-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study