OncoMatch/Clinical Trials/NCT06616636
A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)
Is NCT06616636 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Azacitidine and Rezatapopt for myelodysplastic syndrome.
Treatment: Azacitidine · Rezatapopt — A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Biomarker criteria
Required: TP53 Y220C (variant allele frequency >2%)
TP53Y220C mutation confirmed by CLIA-approved local testing with a variant allele frequency >2%
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: 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.
Cannot have received: targeted therapy
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.
Cannot have received: immunotherapy
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.
Cannot have received: investigational anticancer agent
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.
Cannot have received: radiation therapy
Patient has received radiotherapy within 14 days.
Lab requirements
Kidney function
Serum creatinine < 2 x ULN or creatinine clearance > 40 mL/min (Cockcroft-Gault, CKD-epi, or MDRD equations)
Liver function
AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to leukemic organ involvement; total bilirubin ≤ 1.5 x ULN (higher if due to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome)
Patient has adequate organ function defined as: AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to leukemic organ involvement. Serum total bilirubin ≤ 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome. Serum creatinine < 2 x ULN or creatinine clearance > 40 mL/min based on validated glomerular filtration rate (GFR) estimation (Cockcroft-Gault, CKD-epi, or MDRD equations).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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