NCT04214860

APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

Phase I Study of APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Aprea Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.

Detailed description

This study will enroll adult male and female patients of age ≥ 18 years with documented diagnosis of AML, according to WHO classification, and documented TP53 mutation which is not benign or likely benign, who also meet the eligibility requirements of this protocol. The study will include a safety lead-in dose-finding portion followed by expansion portion. During the safety lead-in portion of the study, two cohorts will independently enroll patients following a 3 + 3 design. Each cohort will enroll up to 6 patients. The expansion portion will begin once the recommended phase II dose (RP2D) of APR-246 in combination with venetoclax and in combination with venetoclax and azacitidine have been determined in order to assess the antitumor activity of these combinations.

Conditions

• Myeloid Malignancy

Interventions

Type	Name	Description
DRUG	APR-246	APR-246 4.5 g/day
DRUG	Venetoclax	Venetoclax 400 mg once daily
DRUG	Azacitidine	Subcutaneous injection, or intravenous infusion

Timeline

• Start date: 2019-12-13
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2020-01-02
• Last updated: 2025-03-17
• Results posted: 2025-02-21

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study