Study of FLD-103 for Nodular Basal Cell Carcinoma
This study is testing a new treatment called FLD-103 for people with nodular basal cell carcinoma (a type of skin cancer). Researchers want to find out if FLD-103 is safe, what dose is best, and if it can shrink tumors. You might be able to join if you are between 18 and 85 years old and have untreated nodular basal cell carcinoma. The main goals are to track any side effects and see how your skin responds to the treatment. This study is currently recruiting 48 participants.
- Study design
- This is an interventional study with a planned enrollment of 48 participants. It is not specified if the study is randomized or blinded.
- What's involved
- Participants will receive FLD-103 injections once weekly for four weeks. You will also have clinic visits the day after each dose and once weekly for four weeks after treatment for checkups and tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from enrollment until the end-of-study visit, which can be up to 36 or 57 days depending on the treatment group.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07670858
Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)
Recruiting
PHASE1Ages 18–85InterventionalTreatmentFeldan Therapeutics
~48 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Intralesional FLD-103
At a glance
Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Measured over From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
+1 more outcome measured
Conditions
Where it's being run
9 sites across 5 statesNew South Wales3
Queensland3
Kentucky1
New York1
Australian Capital Territory1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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) in the past 4 weeks or are expected to receive it during the study.
You have been diagnosed with a liver or kidney disease that the study doctor considers significant.
You are immunocompromised or have an active infection such as Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C or active Tuberculosis.
You have or had another cancer in the past 5 years
You have a skin condition associated with an increased risk of developing skin cancers (such as Xeroderma Pigmentosum).
You have uncontrolled high blood pressure or a heart rhythm problem.
You have had significant alcohol or drug use issues in the past 6 months, or have a mental health condition that the study doctor believes may affect your ability to participate safely.
You are currently taking certain medications that are not allowed during the study
You are an employee or family member of an employee at the study site or of the study doctor.
What this trial measures
- Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)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 responsesFrom enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)