drugset / Trial / NCT06731699
A Phase 1 Study of FD-001 in Recurrent /Refractory (R/R)AML/NHL/MM/MDS
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-03-11
- Primary completion
- 2026-01-24
- Completion
- 2026-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FD-001 | Vaccine | 0.4 mg | Oral |
| Subject | FD-001 | Vaccine | 0.8 mg | Oral |
| Subject | FD-001 | Vaccine | 1.6 mg | Oral |
| Subject | FD-001 | Vaccine | 2.4 mg | Oral |
| Subject | FD-001 | Vaccine | 3.2 mg | Oral |
| Subject | FD-001 | Vaccine | 4 mg | Oral |