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

25. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

48

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Rekruttering
        • Woden Dermatology
    • New South Wales
      • Charlestown, New South Wales, Australia, 2290
        • Rekruttering
        • Novatrials
      • Randwick, New South Wales, Australia, 2031
        • Rekruttering
        • Scientia Clinical Research
      • Waitara, New South Wales, Australia, 2077
        • Rekruttering
        • Innovate Clinical Research
    • Queensland
      • Westcourt, Queensland, Australia, 4870
        • Rekruttering
        • FNQH Cairns Skin Cancer Clinic
      • Woolloongabba, Queensland, Australia, 4102
        • Rekruttering
        • Veracity Clinical Research
      • Woolloongabba, Queensland, Australia, 4102
        • Rekruttering
        • Translational Research Institute
  • Forente stater
    • Kentucky
      • Bowling Green, Kentucky, Forente stater, 42104
        • Rekruttering
        • Equity Medical
    • New York
      • New York, New York, Forente stater, 10023
        • Har ikke rekruttert ennå
        • Equity Medical

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tidsramme
Maximum observed concentration (Cmax)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tidsramme
Rate of histological clearance of the nBCC
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Feldan Therapeutics

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. oktober 2024

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

22. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

26. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • P01-CLIN01
  • ACTRN12624001138572 (Annen identifikator: ANZCTR)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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