RecruitingPhase 1NCT06616636
A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)
Sponsor
M.D. Anderson Cancer Center
Enrollment
24 participants
Start Date
Jan 30, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This trial is testing the combination of rezatapopt (a drug that reactivates the tumor-suppressing function of the p53 protein) and azacitidine (a chemotherapy drug) in people with certain blood cancers — specifically acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) — that carry a specific genetic mutation called TP53 Y220C. These cancers have relapsed or stopped responding to prior treatment.
**You may be eligible if...**
- You are 18 or older
- You have AML or MDS that has relapsed or did not respond to prior treatment
- Your tumor has the specific TP53 Y220C mutation confirmed by an approved lab test
- You are in reasonable general health (ECOG score ≤ 2)
- Your liver, kidneys, and other organs are functioning adequately
- You are not considered a good candidate for intensive chemotherapy
**You may NOT be eligible if...**
- You do not have the TP53 Y220C mutation
- You have had certain prior stem cell transplant complications
- Your organ function does not meet the study requirements
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGAzacitidine
Given by IV
DRUGRezatapopt
Given orally with food
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06616636
Related Trials
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
NCT05554393177 locations
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
NCT06317649220 locations
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
NCT05564390346 locations
Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
NCT05554406220 locations
Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment
NCT0495389721 locations