OncoMatch/Clinical Trials/NCT04581512
Study to Evaluate the Safety and Tolerability of EP0042
Is NCT04581512 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including EP0042 and Venetoclax for acute myeloid leukemia.
Treatment: EP0042 · Venetoclax · Azacitidine (AZA) — A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: FLT3 wild-type
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any prior therapy — relapsed or refractory
relapsed from or are refractory to previous therapy and have failed all (or are not eligible for/intolerant to) available approved therapies for their disease
Cannot have received: systemic anti-cancer therapy
Exception: hydroxyurea permitted throughout screening and first 6 cycles
Systemic anti-cancer therapy for the disease under study within 2 weeks of the first dose of study treatment. Concomitant hydroxyurea is acceptable and will be permitted throughout the screening period and during first 6 cycles of study treatment
Cannot have received: transplantation (allogeneic or autologous)
Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks
Lab requirements
Kidney function
Creatinine clearance (Cockcroft-Gault or measured) ≥ 50 mL/min
Liver function
total serum bilirubin < 1.5 x ULN; ALT < 3 x ULN; AST < 3 x ULN; AST or ALT < 5 x ULN in the presence of liver involvement by leukemia
Creatinine clearance < 50 mL/min excluded; total serum bilirubin ≥ 1.5 x ULN, ALT ≥3 x ULN, AST ≥3 x ULN, or AST/ALT ≥5 x ULN with liver involvement by leukemia excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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