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

25 juni 2026 bijgewerkt door: Feldan Therapeutics

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?

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

48

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Australië
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australië, 2606
        • Werving
        • Woden Dermatology
    • New South Wales
      • Charlestown, New South Wales, Australië, 2290
        • Werving
        • Novatrials
      • Randwick, New South Wales, Australië, 2031
        • Werving
        • Scientia Clinical Research
      • Waitara, New South Wales, Australië, 2077
        • Werving
        • Innovate Clinical Research
    • Queensland
      • Westcourt, Queensland, Australië, 4870
        • Werving
        • FNQH Cairns Skin Cancer Clinic
      • Woolloongabba, Queensland, Australië, 4102
        • Werving
        • Veracity Clinical Research
      • Woolloongabba, Queensland, Australië, 4102
        • Werving
        • Translational Research Institute
  • Verenigde Staten
    • Kentucky
      • Bowling Green, Kentucky, Verenigde Staten, 42104
        • Werving
        • Equity Medical
    • New York
      • New York, New York, Verenigde Staten, 10023
        • Nog niet aan het werven
        • Equity Medical

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: SAD Dose 1
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: SAD Dose 2
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: SAD Dose 3
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: SAD Dose 4
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: MAD Dose 1
A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: MAD Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: MAD Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: MAD Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: MAD-FV Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: MAD-FV Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Experimenteel: MAD-FV Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Geneesmiddel: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Tijdsspanne: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
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
Tijdsspanne: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Maximum observed concentration (Cmax)
Tijdsspanne: From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)
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)
Tijdsspanne: From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)
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)
Tijdsspanne: From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)
From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)

Andere uitkomstmaten

Uitkomstmaat
Tijdsspanne
Rate of histological clearance of the nBCC
Tijdsspanne: End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
Overall response rate (ORR)
Tijdsspanne: End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
Complete response rate (CRR)
Tijdsspanne: End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)
End-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Feldan Therapeutics

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 oktober 2024

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 maart 2027

Studieregistratiedata

Eerst ingediend

22 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2026

Eerst geplaatst (Werkelijk)

26 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • P01-CLIN01
  • ACTRN12624001138572 (Andere identificatie: ANZCTR)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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