NCT07670858

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
7mo left

Started Oct 2024

Typical duration for phase_1

Geographic Reach
2 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Oct 2024Mar 2027

Study Start

First participant enrolled

October 30, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

June 22, 2026

Last Update Submit

June 25, 2026

Conditions

Nodular Basal Cell Carcinoma

Keywords

nBCCIntralesional

Outcome Measures

Primary Outcomes (2)

  • 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 responses

    From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)

Secondary Outcomes (3)

  • Maximum observed concentration (Cmax)

    From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)

  • Time to Cmax (Tmax)

    From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)

  • 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/MAD-FV)

Other Outcomes (3)

  • Rate of histological clearance of the nBCC

    End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)

  • Overall response rate (ORR)

    End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)

  • Complete response rate (CRR)

    End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)

Study Arms (11)

SAD Dose 1

EXPERIMENTAL

A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)

Drug: Intralesional FLD-103

SAD Dose 2

EXPERIMENTAL

A single dose of FLD-103 1 mg/mL (lesion size-determined volume)

Drug: Intralesional FLD-103

SAD Dose 3

EXPERIMENTAL

A single dose of FLD-103 3 mg/mL (lesion size-determined volume)

Drug: Intralesional FLD-103

SAD Dose 4

EXPERIMENTAL

A single dose of FLD-103 5 mg/mL (lesion size-determined volume)

Drug: Intralesional FLD-103

MAD Dose 1

EXPERIMENTAL

A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).

Drug: Intralesional FLD-103

MAD Dose 2

EXPERIMENTAL

A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).

Drug: Intralesional FLD-103

MAD Dose 3

EXPERIMENTAL

A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).

Drug: Intralesional FLD-103

MAD Dose 4

EXPERIMENTAL

A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).

Drug: Intralesional FLD-103

MAD-FV Dose 2

EXPERIMENTAL

A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).

Drug: Intralesional FLD-103

MAD-FV Dose 3

EXPERIMENTAL

A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).

Drug: Intralesional FLD-103

MAD-FV Dose 4

EXPERIMENTAL

A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).

Drug: Intralesional FLD-103

Interventions

Intralesional FLD-103DRUG

Intralesional and perilesional injection of FLD-103

MAD Dose 1MAD Dose 2MAD Dose 3MAD Dose 4MAD-FV Dose 2MAD-FV Dose 3MAD-FV Dose 4SAD Dose 1SAD Dose 2SAD Dose 3SAD Dose 4

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Equity Medical

Bowling Green, Kentucky, 42104, United States

RECRUITING

Equity Medical

New York, New York, 10023, United States

NOT YET RECRUITING

Woden Dermatology

Phillip, Australian Capital Territory, 2606, Australia

RECRUITING

Novatrials

Charlestown, New South Wales, 2290, Australia

RECRUITING

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

RECRUITING

Innovate Clinical Research

Waitara, New South Wales, 2077, Australia

RECRUITING

FNQH Cairns Skin Cancer Clinic

Westcourt, Queensland, 4870, Australia

RECRUITING

Translational Research Institute

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Central Study Contacts

Catherine Lippé

CONTACT

1 581-397-8597clippe@feldan.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: This study will use a traditional 3 + 3 design for both SAD and MAD Cohorts with lesion size-determined volume of FLD-103. After review of both SAD and MAD at Dose Level 2, at the discretion of the sponsor, cohorts with fixed 2 mL volume dosing may be investigated. MAD-fixed volume Cohorts may enrol three (3) or six (6) subjects, based on emerging safety and preliminary efficacy data, in sequence (not following the 3 + 3 design).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

October 30, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations

US(2)AU(7)