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

25 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

48

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Reclutamento
        • Woden Dermatology
    • New South Wales
      • Charlestown, New South Wales, Australia, 2290
        • Reclutamento
        • Novatrials
      • Randwick, New South Wales, Australia, 2031
        • Reclutamento
        • Scientia Clinical Research
      • Waitara, New South Wales, Australia, 2077
        • Reclutamento
        • Innovate Clinical Research
    • Queensland
      • Westcourt, Queensland, Australia, 4870
        • Reclutamento
        • FNQH Cairns Skin Cancer Clinic
      • Woolloongabba, Queensland, Australia, 4102
        • Reclutamento
        • Veracity Clinical Research
      • Woolloongabba, Queensland, Australia, 4102
        • Reclutamento
        • Translational Research Institute
  • Stati Uniti
    • Kentucky
      • Bowling Green, Kentucky, Stati Uniti, 42104
        • Reclutamento
        • Equity Medical
    • New York
      • New York, New York, Stati Uniti, 10023
        • Non ancora reclutamento
        • Equity Medical

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SAD Dose 1
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: SAD Dose 2
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: SAD Dose 3
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: SAD Dose 4
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: MAD Dose 1
A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: MAD Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: MAD Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: MAD Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: MAD-FV Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: MAD-FV Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
Sperimentale: MAD-FV Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
Droga: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Maximum observed concentration (Cmax)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Lasso di tempo
Rate of histological clearance of the nBCC
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Feldan Therapeutics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 ottobre 2024

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

22 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • P01-CLIN01
  • ACTRN12624001138572 (Altro identificatore: ANZCTR)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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