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

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

March 11, 2024

Primary Completion Date

January 24, 2026

Study Completion Date

March 1, 2026

Conditions
AMLNHL
Interventions
DRUG

FD-001

"The initial dose was 0.4mg, and subsequent doses of 0.8mg, 1.6mg, 2.4mg, 3.2mg, and 4.0mg were proposed to be administered in a progressive manner using the rapid titration method combined with the traditional 3+3 experimental design. The trial process consists of three periods: screening period, treatment period, and follow-up period. The screening period lasted from D-28 to D-1 for treatment (DLT observation period): during this time frame, there was a single administration period (C0D1-C0D4) where oral administration occurred on day one followed by safety observations on days two to four; as well as multiple administration period one (C1D1-C1D28) where oral administration took place on days one to two and seven to nine with rest periods in between. The drug is available in capsule form."

Trial Locations (1)

610041

RECRUITING

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
lead

Chengdu FenDi Pharmaceutical Co., Ltd.

INDUSTRY

NCT06731699 - A Phase 1 Study of FD-001 in Recurrent /Refractory (R/R)AML/NHL/MM/MDS | Biotech Hunter | Biotech Hunter