New shot could zap skin cancer without surgery
NCT ID NCT07670858
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This early-phase trial tests an injected drug called FLD-103 for nodular basal cell carcinoma, a common skin cancer. About 48 adults will receive either one or several injections directly into their tumor. The main goal is to check safety and find the right dose, while also seeing if the injection shrinks the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FLD-103 (injected into the tumor)
- What this could lead to
- If it works, this could lead to a new way to treat basal cell skin cancer without surgery.
- What could go wrong
- This is a very early, small trial (48 people) testing safety first. It may not shrink tumors or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Equity Medical
RECRUITINGBowling Green, Kentucky, 42104, United States
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Equity Medical
NOT_YET_RECRUITINGNew York, New York, 10023, United States
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FNQH Cairns Skin Cancer Clinic
RECRUITINGWestcourt, Queensland, 4870, Australia
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Innovate Clinical Research
RECRUITINGWaitara, New South Wales, 2077, Australia
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Novatrials
RECRUITINGCharlestown, New South Wales, 2290, Australia
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Scientia Clinical Research
RECRUITINGRandwick, New South Wales, 2031, Australia
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Translational Research Institute
RECRUITINGWoolloongabba, Queensland, 4102, Australia
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Veracity Clinical Research
RECRUITINGWoolloongabba, Queensland, 4102, Australia
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Woden Dermatology
RECRUITINGPhillip, Australian Capital Territory, 2606, Australia
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