A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression

What this Trial Is About

Researchers are studying AZD3632, an oral drug, in people with advanced blood cancers like acute leukemia and myelodysplastic syndromes that have specific genetic changes linked to HOX gene overexpression. This early-phase, open-label study aims to understand how safe and tolerable AZD3632 is, how the body processes it, and its initial effects when given alone or with other cancer drugs. The study includes participants whose disease has returned or not responded to standard treatments and who have limited approved therapy options. The study has two parts: Module 1 tests increasing doses of AZD3632 by itself to find the best dose, while Module 2 looks at the safety and drug behavior when AZD3632 is combined with another oral drug, posaconazole. Participants receive one of several AZD3632 dose levels or AZD3632 plus posaconazole during the treatment period. Treatment continues according to the assigned dose or combination throughout the study. Participants will be closely monitored for side effects, changes in drug levels in the body, and disease response. Researchers will measure dose-limiting toxicities, adverse events, and various pharmacokinetic markers over about three years. The study will also assess outcomes like response rates, survival, and need for further stem cell transplants. This long observation helps understand the drug's safety and effects over time.

Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression