A Phase 1 Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)

A Phase 1, First-In-Human, Single and Multiple Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Efficacy of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC).

The goal of this clinical trial is to determine safety, tolerability, pharmacokinetics, preliminary efficacy, and 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 dose (SAD) of FLD-103 or multiple 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 Overview

• Status: Recruiting
• Conditions: Nodular Basal Cell Carcinoma
• Intervention / Treatment: Drug: Intralesional FLD-103

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Catherine Lippé; Phone Number: 1 581-397-8597; Email: clippe@feldan.com

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Recruiting
      • Woden Dermatology
  • New South Wales
    • Charlestown, New South Wales, Australia, 2290
      • Recruiting
      • Novatrials
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Scientia Clinical Research
    • Waitara, New South Wales, Australia, 2077
      • Recruiting
      • Innovate Clinical Research
  • Queensland
    • Westcourt, Queensland, Australia, 4870
      • Recruiting
      • FNQH Cairns Skin Cancer Clinic
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Veracity Clinical Research
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Translational Research Institute
• United States
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Recruiting
      • Equity Medical
  • New York
    • New York, New York, United States, 10023
      • Not yet recruiting
      • Equity Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 UVA or UVB 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Dose 1; A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: SAD Dose 2; A single dose of FLD-103 1 mg/mL (lesion size-determined volume)	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: SAD Dose 3; A single dose of FLD-103 3 mg/mL (lesion size-determined volume)	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: SAD Dose 4; A single dose of FLD-103 5 mg/mL (lesion size-determined volume)	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: MAD Dose 1; A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: MAD Dose 2; A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: MAD Dose 3; A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: MAD Dose 4; A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: MAD-FV Dose 2; A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: MAD-FV Dose 3; A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103
Experimental: MAD-FV Dose 4; A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).	Drug: Intralesional FLD-103; Intralesional and perilesional injection of FLD-103

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
Local Skin Response (LSR) and other potential localised responses	From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD)

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax)	From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD)
Time to Cmax (Tmax)	From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD)
Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUClast)	From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD)

Other Outcome Measures

Outcome Measure	Time Frame
Rate of histological clearance of the nBCC	End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD)
Overall response rate (ORR)	End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD)
Complete response rate (CRR)	End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD)

Collaborators and Investigators

• Sponsor: Feldan Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Intralesional; nBCC
• Other Study ID Numbers: P01-CLIN01; ACTRN12624001138572 (Other Identifier: ANZCTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No