Actively Recruiting
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
Led by Chengdu FenDi Pharmaceutical Co., Ltd. · Updated on 2024-12-17
72
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating FD-001 capsules in a phase I clinical trial to study their safety, tolerability, how the body processes the drug, and early signs of effectiveness in adults with recurrent or refractory blood cancers such as acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM). The trial aims to find the highest dose patients can tolerate and recommend a dose for further studies. This open-label study has two main phases: dose escalation and dose expansion. Participants receive FD-001 orally in capsule form following a schedule that starts with a single dose and safety monitoring, then moves to multiple doses given on specific days within a 28-day cycle. The initial dose is 0.4 mg, with planned increases up to 4.0 mg using a stepwise method combined with a traditional design to find the best dose. After initial evaluation, patients who tolerate the drug may continue with maintenance cycles of treatment for 28 days each, taking capsules on certain days and resting on others. Throughout the study, participants undergo screening before treatment, receive scheduled doses during treatment, and have follow-up assessments after. Blood samples are collected during the first treatment cycle to study drug levels and metabolism. Researchers monitor safety, tolerability, and response to treatment up to about 12 months, including dose limiting toxicities and maximum tolerated doses. The total treatment period includes precise observation windows, and the study team carefully tracks outcomes to guide future research.
CONDITIONS
Brief 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 and able to provide signed informed consent
- Aged between 18 and 80 years, any gender
- ECOG performance status of 2 or less
- Expected survival of at least 3 months
- Diagnosed with recurrent or refractory hematological malignancies confirmed by pathology or cytology
- At least one measurable lesion as defined for AML, MDS, MM, or NHL
- Recovery from prior anti-cancer therapy side effects to grade 1 or less (except continuous hair loss)
- Adequate organ function and specified blood counts within required ranges before treatment start
You will not qualify if you...
- Received anti-cancer therapy within 4 weeks or radiation therapy within 2 weeks before starting the study drug
- Diagnosis of chronic myeloid leukemia with BCR/ABL positivity
- Presence of central nervous system malignant tumor infiltration
- Having another active malignant tumor except certain cured or fully remitted cancers
- Received live vaccines within 4 weeks before starting the study drug
- History of alcohol or drug abuse, severe allergies, or allergy to study drug components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 32 days for initial treatment and continued 28-day cycles during maintenance if eligible
Participants receive FD-001 capsules in a dose-escalation and expansion design with an initial single administration phase followed by multiple administration phases and maintenance treatment cycles.
1 initial treatment cycle with daily dosing on specific days and subsequent 28-day maintenance cycles with oral dosing on days 1-3 and 8-10 per cycle
Duration - Up to approximately 12 months
Participants are monitored for safety and efficacy outcomes after treatment completion.
Periodic visits for assessment during follow-up
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
G
Guobing Yang
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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