Phase 12 Study of Tuspetinib Alone or with Venetoclax and Azacitidine in Adults with Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia

What this Trial Is About

Researchers are studying the safety, tolerability, and pharmacokinetics of tuspetinib HM43239 in adults with acute myeloid leukemia AML, myelodysplastic syndromes with increased blasts grade 2 MDS-IB2, or chronic myelomonocytic leukemia CMML that has relapsed or is refractory after at least one prior treatment, as well as in newly diagnosed AML patients who cannot receive intensive chemotherapy. This phase 12 open-label study aims to find a safe and potentially effective dose of tuspetinib for future research. Tuspetinib will be given either alone or combined with other drugs such as venetoclax or venetoclax plus azacitidine, depending on the study part. The study includes several parts Part A dose escalation with up to 6 dose levels of tuspetinib alone, Part B dose exploration at up to 4 dose levels, Part C dose expansion testing tuspetinib alone or with venetoclax at specified doses, and Part D dose exploration combining tuspetinib with venetoclax and azacitidine for newly diagnosed AML patients ineligible for intensive chemotherapy. Participants will be closely monitored through blood tests, physical exams, and assessments of drug levels in the blood during at least one 28-day treatment cycle and up to four years for long-term safety and response. Researchers will measure adverse events, determine the maximum tolerated dose, and evaluate treatment responses such as remission rates and survival outcomes. The study involves multiple centers and aims to provide detailed information on how tuspetinib works and is tolerated alone and in combination treatments.

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia