A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)
M.D. Anderson Cancer Center
Summary
A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Patient is willing and able to adhere to the study visit schedule and other protocol requirements. 3. Patient has relapsed or primary refractory AML or MDS 4. Any other comorbidity that per the investigator renders a patient inappropriate for intensive chemotherapy. 5. Patients with MDS must be classified as MDS-IB1 or IB2 as per WHO 2022 criteria32 6. TP53Y220C mutation confirmed by CLIA-approved local testing with a variant allele frequency \>2%. 7. Patient has an Eastern Cooper…
Interventions
- DrugAzacitidine
Given by IV
- DrugRezatapopt
Given orally with food
Location
- The University of Texas MD Anderson Cancer CenterHouston, Texas