What is FLD-103 studying for nodular basal cell carcinoma?

FLD-103 is being studied to find out if it is safe and well tolerated when injected directly into skin cancer lesions. Researchers also want to learn the best dose to use and whether the drug can reduce the size of the tumors. Feldan Therapeutics is leading this research to help guide future treatment studies.

Who may be eligible for this nodular basal cell carcinoma clinical trial?

Adults between 18 and 85 years old with a diagnosis of untreated nodular basal cell carcinoma may be eligible. Participants should not be breastfeeding, should avoid certain medications during the study, and must be willing to follow study visits and procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this nodular basal cell carcinoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 85Years

All Genders

ID07670858

Phase 1 Study Evaluating Safety and Dose of Intralesional FLD-103 in Adults with Nodular Basal Cell Carcinoma

Led by Feldan Therapeutics · Updated on 2026-06-29

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, drug behavior, and early effects of intralesional FLD-103 in adults with nodular basal cell carcinoma BCC, a type of skin cancer. This Phase 1 trial aims to find a safe dose for future studies and to see if FLD-103 can reduce tumor size. The main questions are about FLD-103s safety, how it moves through and clears from the body, and whether it shrinks tumors. Participants will receive either a single ascending dose SAD or multiple ascending doses MAD of FLD-103 injected into the lesion. Single doses range from 0.5 to 5 mgmL with volumes based on lesion size. Multiple doses are given once weekly for four weeks, with some groups receiving fixed volumes. The study has several dose levels to determine the maximum tolerable dose. During the trial, participants will visit the clinic the day after dosing and weekly for up to four weeks for checkups and tests. Researchers will monitor adverse events and local skin reactions from enrollment until study end up to 36 days for single dose groups and 57 days for multiple dose groups. Blood levels of FLD-103 will be measured to understand how much enters the bloodstream and how long it stays. The total participation lasts up to about two months depending on the dosing group.

CONDITIONS

Brief Title

Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)

Who Can Participate

Age: 18Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

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 that has never been treated and is suitable for treatment and final removal by the investigator.
You agree to avoid certain medications during the study as directed 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 the last dose, and not breastfeed during this time.
If you are a man, you must use a condom during the study and for 90 days after the last dose if you have sex with a partner who could become pregnant.

You will not qualify if you...

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, 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 expect to receive it during the study.
You have been diagnosed with significant liver or kidney disease.
You are immunocompromised or have an active infection like HIV, Hepatitis B, Hepatitis C, or active Tuberculosis.
You have had another cancer in the past 5 years.
You have a skin condition with increased risk of 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 a mental health condition that may affect safe participation.
You are currently taking medications not allowed during the study.
You are an employee or family member of an employee at the study site or of the study doctor.

Research Team

Catherine Lippé

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Phase 1 Study Evaluating Safety and Dose of Intralesional FLD-103 in Adults with Nodular Basal Cell Carcinoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria