NCT06731699

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

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of FD-001 in Patients with Relapsed or Refractory Hematological Malignancies.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Chengdu FenDi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, dose-escalation and dose-expansion phase I clinical trial aimed at assessing the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary efficacy of FD-001 capsules in the treatment of recurrent/refractory hematologic malignancies(AML/MDS/NHL/MM). The trial consists of two phases: the initial phase (dose escalation) and the subsequent phase (dose expansion). The primary objectives are to evaluate the safety and tolerability of FD-001 in subjects with recurrent/refractory hematologic tumors and determine the maximum tolerated dose (MTD) as well as the recommended Phase II dose (RP2D) for FD-001 in this patient population.

Detailed description

This is a single-arm, open-label, dose-escalation and dose-expansion phase I clinical trial aimed at assessing the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary efficacy of FD-001 capsules in the treatment of recurrent/refractory hematologic malignancies(AML/MDS/NHL/MM).The trial process consists of three periods: the screening period, the treatment period, and the follow-up period. The screening period occurred from D-28 to D-1. The treatment period (DLT observation period) includes a single administration phase (C0D1-C0D4) (oral administration on D1, followed by safety observation from D2-D4), as well as multiple administration phase 1 (C1D1-C1D28) (oral administration on D1-D2 and D7-D9, with withdrawal for the remaining time). Blood samples were collected in the first cycle (C1D1\~C1D28) for PK study, and part of the PK test blood samples may be used for metabolite identification.After completion of the DLT evaluation, subjects without intolerable toxicity may enter the maintenance treatment period if determined by the investigator that continued treatment outweighs risks. The maintenance treatment period lasts for 28 days per cycle (CND1-CND28), with oral administration on D1-D3 and D8-D10 per cycle, while withdrawing for the rest of the time.

Conditions

• AML
• NHL

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-11
• Primary completion: 2026-01-24
• Completion: 2026-03-01
• First posted: 2024-12-12
• Last updated: 2024-12-17

Locations

1 site across 1 country: China