NCT07508982

Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML.

Detailed description

Primary Objectives: Phase Ib: To evaluate the safety, tolerability, and maximum tolerated dose of APG1252 in combination with Azacitidine in patients with relapsed or refractory (R/R) high-risk Acute Myeloid Leukemia (AML) Phase II: To evaluate the initial efficacy information in terms of ORR (CR/CRi/MLFS). Secondary Objectives: * \[Phase Ib\] To evaluate response (complete response \[CR\] including complete response without blood count recovery \[CRi\] or marrow leukemia free state \[MLFS\]) of APG1252 in combination with Azacitidine * \[Phase Ib and Phase II\] To evaluate the event free survival of APG1252 in combination with Azacitidine in patients with high-risk AML * \[Phase Ib and Phase II\] To assess the time to response, response duration, relapse-free survival, and overall survival (OS) in patients with AML treated with APG1252 in combination with Azacitidine Although the clinical benefit of this drug has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Azacitidine	Given by IV
DRUG	APG1252	Given by IV

Timeline

• Start date: 2026-09-01
• Primary completion: 2029-12-12
• Completion: 2031-12-12
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study