A Study Evaluating Safety, Tolerability and Clinical Activity of FHND6091 in Patients With Multiple Myeloma
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
This is a phase I, first in human, single arm, open label study that will assess safety,
tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule
by patients with relapsed and refractory multiple myeloma (RRMM).The study will consist of
two parts: dose escalation (Part 1) and dose expansion (Part 2).The dose escalation (Part 1)
of the study will evaluate the safety and tolerability of FHND6091 using a dose escalation
scheme to establish a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).
And the dose expansion (Part B) of the study will further evaluate the safety,
pharmacokinetics (PK)/ pharmacodynamics (PD), and efficacy of FHND6091 at two selected dose
levels to characterize the safety, tolerability and efficacy of FHND6091.
A total of 40 evaluable participants will be enrolled in the study. The participants
receiving treatment in part 1 and part 2 may continue combination treatment for a total of up
to 12 cycles. After 12 cycles of therapy, the participants will continue treatment until the
occurrence of PD, intolerable AEs, consent withdrawal, death or end of study based on the
judgement of investigator's assessment.