Actively Recruiting
A Phase 1 Study of FD-001 in Recurrent /Refractory (R/R)AML/NHL/MM/MDS
Led by Chengdu FenDi Pharmaceutical Co., Ltd. · Updated on 2024-12-17
72
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of FD-001 in Recurrent /Refractory (R/R)AML/NHL/MM/MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate voluntarily with informed consent and complete all study procedures
- Age between 18 and 80 years, any gender
- ECOG performance status of 2 or less
- Expected to survive at least 3 months
- Diagnosed with recurrent or refractory hematological malignancies confirmed by pathology or cytology, including AML, MDS, NHL, MM
- At least one measurable lesion specific to the type of malignancy (e.g., bone marrow blast percentage, monoclonal protein levels, or lesion size by imaging)
- Side effects from prior cancer therapy must have recovered to grade 1 or less (except continuous hair loss)
- Laboratory tests meet specific blood cell counts and hemoglobin levels with allowances for bone marrow infiltration and no recent growth factor or transfusion treatments
You will not qualify if you...
- Received anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy except hydroxyurea) within 4 weeks or radiation therapy within 2 weeks before first dose
- Chronic myeloid leukemia with BCR/ABL positivity
- Central nervous system malignant tumor infiltration
- Another concurrent malignant tumor except certain cured or low-stage cancers
- Received live vaccine within 4 weeks before first dose
- History of clear alcohol or drug abuse, severe allergies, or allergy to study drug components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
G
Guobing Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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