Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC) (NCT07670858) | Clinical Trial Compass
RecruitingPhase 1
Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)
United States, Australia48 participantsStarted 2024-10-30
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* You are currently breastfeeding.
* You have a known allergy or sensitivity to any ingredient in the study drug or to red tattoo ink.
* Your skin lesion is located in a high-risk area, such as near the eyes, nose, ears, lips, scalp, or on the hands or fingers.
* Your skin lesion needs to be removed urgently.
* Your basal cell carcinoma has spread to other parts of the body.
* You have received radiation therapy directly on or near the skin lesion being treated in this study.
* You have received phototherapy (such as Ultraviolet A or B light therapy…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Timeframe: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
2
Local Skin Response (LSR) and other potential localised responses
Timeframe: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)