Actively Recruiting
A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)
Led by M.D. Anderson Cancer Center · Updated on 2026-02-18
24
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
M
Memorial Sloan Kettering Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.
CONDITIONS
Official Title
A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older at the time of signing informed consent.
- Willing and able to follow the study visit schedule and protocol requirements.
- Diagnosed with relapsed or primary refractory acute myeloid leukemia or myelodysplastic syndrome.
- Presence of TP53Y220C mutation confirmed by approved local testing with variant allele frequency above 2%.
- For MDS patients, classified as MDS-IB1 or IB2 according to WHO 2022 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Adequate organ function with specific liver and kidney test thresholds.
- Females of childbearing potential must have negative pregnancy tests and agree to effective contraception during and after the study.
- Men and women of childbearing potential must agree to use effective contraception starting 14 days before study entry and throughout participation.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Received chemotherapy, targeted therapy, immunotherapy, or investigational anticancer agent within 14 days or 5 half-lives before study drug.
- Received radiotherapy within 14 days prior to study treatment.
- Diagnosis of acute promyelocytic leukemia.
- Immediate life-threatening or severe leukemia complications such as uncontrolled bleeding or pneumonia with hypoxia.
- Active, uncontrolled central nervous system involvement of leukemia.
- Known active infection with HIV, hepatitis B, or hepatitis C.
- Conditions limiting oral drug intake or absorption such as dysphagia or gastroparesis.
- Active uncontrolled systemic infections despite treatment.
- Unresolved toxicities greater than Grade 1 from prior anticancer therapy, except alopecia and certain neuropathies.
- Major surgery within 2 weeks before starting study treatment.
- Pregnancy or lactation.
- History of allergic reactions to azacitidine, rezetapopt, or similar agents.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Courtney DiNardo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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