NCT06616636

A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.

Detailed description

Primary Objective: To assess the safety and tolerability of rezatapopt in TP53Y220C -mutant myeloid malignancies (AML, MDS) Secondary Objectives: 1. To determine the clinical efficacy of rezatapopt in R/R and newly diagnosed patients with TP53Y220C -mutant myeloid malignancies 2. To assess event free survival (EFS) and overall survival (OS) in patients receiving rezatapopt in combination with AZA +/- VEN 3. To assess duration of response in patients receiving rezatapopt in combination with AZA 4. Characterize the pharmacokinetics of rezatapopt in combination with AZA Exploratory Objectives: 1. To assess changes in the variant allele frequencies of TP53Y220C mutations via next-generation sequencing. 2. To describe mutational profiles of patients on study at screening, response and at relapse and correlate to clinical parameters. 3. To assess changes in clonal architecture based on bone marrow aspirate samples using single cell sequencing. 4. To evaluate for p53 activation and changes in the immunologic profile of patients of TP53Y220C mutations.

Conditions

• Myelodysplastic Syndrome
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine	Given by IV
DRUG	Rezatapopt	Given orally with food

Timeline

• Start date: 2025-01-30
• Primary completion: 2027-08-27
• Completion: 2029-08-27
• First posted: 2024-09-27
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study