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Nodular Basal Cell CarcinomaPhase 1NCT07670858

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

A Phase 1 study testing Intralesional FLD-103 in people with Nodular Basal Cell Carcinoma, run by Feldan Therapeutics at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Nodular Basal Cell Carcinoma
What is being tested?
Intralesional FLD-103
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
10 sitesin 2 countries
Study dates
30 Oct 2024to 26 Oct 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Australia7 sites

  • Novatrials

    Charlestown, New South Wales, 2290

  • Veracity Clinical Research

    Greenslopes, Queensland, 4120

  • Woden Dermatology

    Phillip, Australian Capital Territory, 2606

  • Scientia Clinical Research

    Randwick, New South Wales, 2031

  • Innovate Clinical Research

    Waitara, New South Wales, 2077

  • FNQH Cairns Skin Cancer Clinic

    Westcourt, Queensland, 4870

  • Translational Research Institute

    Woolloongabba, Queensland, 4102

Other trials in Australia

United States3 sites

  • Equity Medical

    Bowling Green, Kentucky, 42104

  • Equity Medical

    New York, New York, 10023

  • Equity Medical

    Owensboro, Kentucky, 42303

Other trials in United States

About this study

Official title: 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 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?
Read more

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.
Being tested
Intralesional FLD-103
Keywords
nBCC, Intralesional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intralesional FLD-103Drug

    Intralesional and perilesional injection of FLD-103

Study groups in NCT07670858
Study groupRoleWhat they receive
SAD Dose 1ExperimentalA single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
Receives: Drug: Intralesional FLD-103
SAD Dose 2ExperimentalA single dose of FLD-103 1 mg/mL (lesion size-determined volume)
Receives: Drug: Intralesional FLD-103
SAD Dose 3ExperimentalA single dose of FLD-103 3 mg/mL (lesion size-determined volume)
Receives: Drug: Intralesional FLD-103
SAD Dose 4ExperimentalA single dose of FLD-103 5 mg/mL (lesion size-determined volume)
Receives: Drug: Intralesional FLD-103
MAD Dose 1ExperimentalA multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Receives: Drug: Intralesional FLD-103
MAD Dose 2ExperimentalA multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Receives: Drug: Intralesional FLD-103
MAD Dose 3ExperimentalA multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Receives: Drug: Intralesional FLD-103
MAD Dose 4ExperimentalA multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Receives: Drug: Intralesional FLD-103
MAD-FV Dose 2ExperimentalA multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Receives: Drug: Intralesional FLD-103

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)

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

  2. Local Skin Response (LSR) and other potential localised responses

    Measured: 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)

  1. Maximum observed concentration (Cmax)

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

  2. Time to Cmax (Tmax)

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

  3. Area under the concentration-time curve from 0 to time of last quantifiable concentration (AUClast)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2026
  2. Study start30 Oct 2024
  3. Primary completion26 Oct 2026
  4. Study completion26 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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).
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07670858
Sponsor's protocol ID
P01-CLIN01
Other IDs
ACTRN12624001138572
Status last verified
Oct 2026
First submitted
22 Jun 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intralesional FLD-103 in people with Nodular Basal Cell Carcinoma, run by Feldan Therapeutics at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs) (time frame: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07670858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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