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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Intralesional and perilesional injection of FLD-103
Equity Medical
Bowling Green, Kentucky, United States
RECRUITINGEquity Medical
New York, New York, United States
NOT_YET_RECRUITINGWoden Dermatology
Phillip, Australian Capital Territory, Australia
RECRUITINGNovatrials
Charlestown, New South Wales, Australia
RECRUITINGScientia Clinical Research
Randwick, New South Wales, Australia
RECRUITINGInnovate Clinical Research
Waitara, New South Wales, Australia
RECRUITINGFNQH Cairns Skin Cancer Clinic
Westcourt, Queensland, Australia
RECRUITINGTranslational Research Institute
Woolloongabba, Queensland, Australia
RECRUITINGVeracity Clinical Research
Woolloongabba, Queensland, Australia
RECRUITINGFrequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Time frame: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
Local Skin Response (LSR) and other potential localised responses
Time frame: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
Maximum observed concentration (Cmax)
Time frame: From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)
Time to Cmax (Tmax)
Time frame: From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)
Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUClast)
Time frame: From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)
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