Phase 1 Study of FD-001 Capsules for Safety and Effectiveness in Adults with Relapsed or Refractory Blood Cancers including AML, MDS, NHL, and MM

What this Trial Is About

Researchers are evaluating FD-001 capsules in a phase I clinical trial to study their safety, tolerability, how the body processes the drug, and early signs of effectiveness in adults with recurrent or refractory blood cancers such as acute myeloid leukemia AML, myelodysplastic syndromes MDS, non-Hodgkin lymphoma NHL, and multiple myeloma MM. The trial aims to find the highest dose patients can tolerate and recommend a dose for further studies. This open-label study has two main phases dose escalation and dose expansion. Participants receive FD-001 orally in capsule form following a schedule that starts with a single dose and safety monitoring, then moves to multiple doses given on specific days within a 28-day cycle. The initial dose is 0.4 mg, with planned increases up to 4.0 mg using a stepwise method combined with a traditional design to find the best dose. After initial evaluation, patients who tolerate the drug may continue with maintenance cycles of treatment for 28 days each, taking capsules on certain days and resting on others. Throughout the study, participants undergo screening before treatment, receive scheduled doses during treatment, and have follow-up assessments after. Blood samples are collected during the first treatment cycle to study drug levels and metabolism. Researchers monitor safety, tolerability, and response to treatment up to about 12 months, including dose limiting toxicities and maximum tolerated doses. The total treatment period includes precise observation windows, and the study team carefully tracks outcomes to guide future research.

A Phase 1 Study of FD-001 in Recurrent /Refractory (R/R)AML/NHL/MM/MDS