Clinical Trial

Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)

Recruiting Phase 1
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Summary
The goal of this clinical trial is to determine safety, tolerability, pharmacokinetics, preliminary efficacy, and Maximum Tolerable Dose (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 Ascending Dose (SAD) of FLD-103 or Multiple Ascending 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-22.
Trial Details
NCT Number NCT07670858
Lead Sponsor Feldan Therapeutics
Conditions Nodular Basal Cell Carcinoma
Enrollment 48 participants
Start Date 2024-10-30
Primary Completion 2027-02 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-29