Phase 1 Study of TQB3455 Tablets Alone or With Azacitidine in Adults With Acute Myeloid Leukemia or Myelodysplastic Syndrome and IDH2 Mutation

What this Trial Is About

Researchers are evaluating the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies, specifically acute myeloid leukemia AML and myelodysplastic syndrome MDS. TQB3455 is an inhibitor targeting the IDH2 enzyme. The study has two stages the first focuses on safety and tolerability of single or multiple doses in subjects with malignant blood tumors, while the second investigates the efficacy and safety of TQB3455 alone or combined with azacitidine in AML or MDS patients. During stage one, participants take TQB3455 tablets orally once daily for 28 consecutive days per treatment cycle. In stage two, participants receive the same TQB3455 tablet regimen, and some also receive azacitidine injections subcutaneously on days one through seven of each 4-week cycle. Azacitidine is a drug that affects DNA methylation. The study assesses both single and combination treatments through these cycles. Participants will be monitored with multiple assessments including dose-limiting toxicity and maximum tolerated dose during the first 28 days up to 48 weeks. Researchers will also measure overall remission rates, survival, response duration, and complete remission rates up to 48 weeks, along with detailed pharmacokinetic measurements of TQB3455 over multiple time points. Safety and tolerability are closely followed, and patients will be observed up to 96 weeks for overall survival outcomes.

A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies