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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).
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• You are between 18 and 85 years old.
• You are willing to attend all study visits and follow the study procedures.
• You have been diagnosed with at least one nodular basal cell carcinoma (a type of skin cancer) that has never been treated and suitable for treatment and final excision by the Investigator.
• You are willing to avoid certain medications during the study as instructed by the study doctor.
• You are not currently participating in another clinical study.
• If you are a woman who could become pregnant, you must:
• Have a negative pregnancy test at the start of the study.
• Use effective birth control during the study and for 90 days after your last dose.
• Not breastfeed during the study and for 90 days after your last dose.
• If you are a man, you must use a condom during the study and for 90 days after your last dose if you have sex with a partner who could become pregnant.
Locations
United States
Kentucky
Equity Medical
RECRUITING
Bowling Green
New York
Equity Medical
NOT_YET_RECRUITING
New York
Other Locations
Australia
Novatrials
RECRUITING
Charlestown
Woden Dermatology
RECRUITING
Phillip
Scientia Clinical Research
RECRUITING
Randwick
Innovate Clinical Research
RECRUITING
Waitara
FNQH Cairns Skin Cancer Clinic
RECRUITING
Westcourt
Translational Research Institute
RECRUITING
Woolloongabba
Veracity Clinical Research
RECRUITING
Woolloongabba
Contact Information
Primary
Catherine Lippé
clippe@feldan.com
1 581-397-8597
Time Frame
Start Date:2024-10-30
Estimated Completion Date:2027-03
Participants
Target number of participants:48
Treatments
Experimental: SAD Dose 1
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
Experimental: SAD Dose 2
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
Experimental: SAD Dose 3
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
Experimental: SAD Dose 4
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
Experimental: MAD Dose 1
A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Experimental: MAD Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Experimental: MAD Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Experimental: MAD Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Experimental: MAD-FV Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Experimental: MAD-FV Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Experimental: MAD-FV Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).