A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.
Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
Patient has relapsed or primary refractory AML or MDS
Any other comorbidity that per the investigator renders a patient inappropriate for intensive chemotherapy.
Patient has received prior chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent within 14 days or 5 half-lives (if half-life is known), whichever is shorter, before receiving their first dose of study drug.
Patient has received radiotherapy within 14 days.
Patients with acute promyelocytic leukemia
Subject has immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
Single group
Azacitidine
DrugGiven by IV
Rezatapopt
DrugGiven orally with food
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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M.D. Anderson Cancer Center
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborator
PMV Pharmaceuticals, Inc
Collaborator
