OncoMatch/Clinical Trials/NCT03850574
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Is NCT03850574 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Tuspetinib and Venetoclax Oral Tablet for leukemia, myeloid, acute.
Treatment: Tuspetinib · Venetoclax Oral Tablet · Azacitidine for Intravenous Infusion — The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Excluded: BCR BCR-ABL-positive
Study participant has known BCR-ABL-positive leukemia.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any prior therapy
Refractory to at least 1 cycle of prior therapy OR Relapsed after achieving remission with a prior therapy
Cannot have received: hematopoietic stem cell transplant
Exception: HSCT within the 2-month period prior to the first study dose
Has undergone HSCT within the 2-month period prior to the first study dose
Cannot have received: donor lymphocyte infusion
Exception: DLI ≤ 30 days prior to the first study dose
Had a donor lymphocyte infusion (DLI) ≤ 30 days prior to the first study dose
Cannot have received: tyrosine kinase inhibitor
Exception: history of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitor
history of Grade 3 or 4 non-hematologic toxicity related to tyrosine kinase inhibitor
Cannot have received: major surgery
Exception: within 4 weeks prior to the first study dose
major surgery within 4 weeks prior to the first study dose
Cannot have received: radiation therapy
Exception: within 4 weeks prior to the first study dose
radiation therapy within 4 weeks prior to the first study dose
Lab requirements
Kidney function
Creatinine clearance > 45 mL/min
Liver function
Serum AST and ALT ≤ 3× institutional ULN; total serum bilirubin ≤ 1.5× institutional ULN
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× institutional upper limit normal (ULN); Total serum bilirubin ≤ 1.5× institutional ULN; Creatinine clearance > 45 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Kirklin Clinic of UAB Hospital · Birmingham, Alabama
- City of Hope Comprehensive Cancer Center · Duarte, California
- University of California Irvine · Irvine, California
- UCSD Moores Cancer Center · La Jolla, California
- USC/Norris Comprehensive Cancer Center · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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