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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
FHND6091 capsules
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGThe Third Hosptial of Changsha
Changsha, Hunan, China
RECRUITINGThe Affilitated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGXi'an Central Hospital
Xi'an, Shaanxi, China
RECRUITINGRuijin Hospital
Shanghai, China
RECRUITINGNumber of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events
An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: Baseline to 28 days after first dose of FHND6091 administration
Complete Response/Stringent Complete Response (CR/sCR) Rate
CR/sCR to FHND6091, according to international myeloma working group (IMWG) criteria
Time frame: Baseline to 12 months after first dose of FHND6091 administration
Rate of Very Good Partial Response (VGPR) or Better
VGPR to FHND6091, according to international myeloma working group (IMWG) criteria
Time frame: Baseline to 12 months after first dose of FHND6091 administration
Partial Response (PR)
PR to FHND6091, according to international myeloma working group (IMWG) criteria
Time frame: Baseline to 12 months after first dose of FHND6091 administration
Cmax: Maximum Observed Plasma Concentration for FHND6091
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve for FHND6091
Time frame: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for FHND6091
Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax
Time frame: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for FHND6091
AUC(0-168) is a measure of the area under the plasma concentration-time curve over the dosing interval (tau) (AUC\[0-tau\]), where tau is the length of the dosing interval - 168 hours in this study)
Time frame: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
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