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

Myeloid Malignancy Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04214860
Study type Interventional
Source Aprea Therapeutics
Contact
Status Completed
Phase Phase 1
Start date December 13, 2019
Completion date January 14, 2022
View Details
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