Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)
25. juni 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
48
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Catherine Lippé
- Telefonnummer: 1 581-397-8597
- E-mail: clippe@feldan.com
Studiesteder
-
-
Australian Capital Territory
-
Phillip, Australian Capital Territory, Australien, 2606
- Rekruttering
- Woden Dermatology
-
-
New South Wales
-
Charlestown, New South Wales, Australien, 2290
- Rekruttering
- Novatrials
-
Randwick, New South Wales, Australien, 2031
- Rekruttering
- Scientia Clinical Research
-
Waitara, New South Wales, Australien, 2077
- Rekruttering
- Innovate Clinical Research
-
-
Queensland
-
Westcourt, Queensland, Australien, 4870
- Rekruttering
- FNQH Cairns Skin Cancer Clinic
-
Woolloongabba, Queensland, Australien, 4102
- Rekruttering
- Veracity Clinical Research
-
Woolloongabba, Queensland, Australien, 4102
- Rekruttering
- Translational Research Institute
-
-
-
-
Kentucky
-
Bowling Green, Kentucky, Forenede Stater, 42104
- Rekruttering
- Equity Medical
-
-
New York
-
New York, New York, Forenede Stater, 10023
- Ikke rekrutterer endnu
- Equity Medical
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: SAD Dose 1
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: SAD Dose 2
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: SAD Dose 3
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: SAD Dose 4
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: MAD Dose 1
A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: MAD Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: MAD Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: MAD Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: MAD-FV Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: MAD-FV Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
|
Intralesional and perilesional injection of FLD-103
|
|
Eksperimentel: MAD-FV Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
|
Intralesional and perilesional injection of FLD-103
|
Hvad måler undersøgelsen?
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. oktober 2024
Primær færdiggørelse (Anslået)
1. februar 2027
Studieafslutning (Anslået)
1. marts 2027
Datoer for studieregistrering
Først indsendt
22. juni 2026
Først indsendt, der opfyldte QC-kriterier
22. juni 2026
Først opslået (Faktiske)
26. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- P01-CLIN01
- ACTRN12624001138572 (Anden identifikator: ANZCTR)
Plan for individuelle deltagerdata (IPD)
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Ingen
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