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A Phase 1 Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)
Sponsor: Feldan Therapeutics
Summary
The goal of this clinical trial is to determine safety, tolerability, pharmacokinetics, preliminary efficacy, and MTD, of intralesional FLD-103 when administered to subjects with Basal Cell Carcinoma (BCC). The main questions it aims to answer are: * Is FLD-103 safe and well tolerated? * What is a safe dose of FLD-103 for future studies? * How much FLD-103 enters the bloodstream and how long does it take to be cleared from the body? * Does FLD-103 reduce the size of the tumor? Participants will: * Receive either a single dose (SAD) of FLD-103 or multiple doses (MAD) of FLD-103 once weekly for four (4) weeks. * Visit the clinic a day after receiving a dose and once weekly for four (4) weeks after that for checkups and tests.
Official title: A Phase 1, First-In-Human, Single and Multiple Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Efficacy of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC).
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-10-30
Completion Date
2027-03
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Locations (9)
Equity Medical
Bowling Green, Kentucky, United States
Equity Medical
New York, New York, United States
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Novatrials
Charlestown, New South Wales, Australia
Scientia Clinical Research
Randwick, New South Wales, Australia
Innovate Clinical Research
Waitara, New South Wales, Australia
FNQH Cairns Skin Cancer Clinic
Westcourt, Queensland, Australia
Translational Research Institute
Woolloongabba, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia