Chaser Therapeutics Inc

Primary objective: To evaluate the safety and tolerability of PBSS1113 in the treatment of patients with relapsed/refractory acute myeloid leukemia, and to determine the maximum tolerated dose (MTD) and the recommended dose (RP2D) for Phase II. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia; 2) To evaluate the effect of food on the PK of PBSS1113 in patients with relapsed/refractory myeloid leukemia; 3) To observe the preliminary efficacy of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia. Exploratory objectives: 1) To evaluate the pharmacodynamic (PD) characteristics of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia; 2) To explore the pharmacokinetic (PK) characteristics of the main metabolites of PBSS1113 in patients with relapsed/refractory acute myeloid leukemia.

Phase Ib Primary Objectives To evaluate the safety and tolerability of PBSS1113 combined with azacitidine in patients with AML or MDS, and to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Secondary Objectives 1) To evaluate the pharmacokinetic (PK) characteristics of PBSS1113 combined with azacitidine in patients with AML or MDS. 2) To evaluate the preliminary efficacy of PBSS1113 combined with azacitidine in patients with AML or MDS. Phase II Primary Objectives To evaluate the preliminary efficacy of PBSS1113 combined with azacitidine in patients with AML or MDS. Secondary Objectives 1) To evaluate the safety of PBSS1113 combined with azacitidine in patients with AML or MDS. 2) To evaluate the PK characteristics of PBSS1113 combined with azacitidine in patients with AML or MDS. Exploratory Objectives To explore the effects of CYP3A inhibitors on the PK characteristics of PBSS1113.