Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)
25 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
48
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Catherine Lippé
- Número de teléfono: 1 581-397-8597
- Correo electrónico: clippe@feldan.com
Ubicaciones de estudio
-
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Australian Capital Territory
-
Phillip, Australian Capital Territory, Australia, 2606
- Reclutamiento
- Woden Dermatology
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New South Wales
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Charlestown, New South Wales, Australia, 2290
- Reclutamiento
- Novatrials
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Randwick, New South Wales, Australia, 2031
- Reclutamiento
- Scientia Clinical Research
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Waitara, New South Wales, Australia, 2077
- Reclutamiento
- Innovate Clinical Research
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Queensland
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Westcourt, Queensland, Australia, 4870
- Reclutamiento
- FNQH Cairns Skin Cancer Clinic
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Woolloongabba, Queensland, Australia, 4102
- Reclutamiento
- Veracity Clinical Research
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Woolloongabba, Queensland, Australia, 4102
- Reclutamiento
- Translational Research Institute
-
-
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Kentucky
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Bowling Green, Kentucky, Estados Unidos, 42104
- Reclutamiento
- Equity Medical
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New York
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New York, New York, Estados Unidos, 10023
- Aún no reclutando
- Equity Medical
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: SAD Dose 1
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
Experimental: SAD Dose 2
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
Experimental: SAD Dose 3
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
Experimental: SAD Dose 4
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
|
Experimental: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Periodo de tiempo: 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)
|
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Local Skin Response (LSR) and other potential localised responses
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Maximum observed concentration (Cmax)
Periodo de tiempo: 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)
Periodo de tiempo: From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)
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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)
Periodo de tiempo: 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)
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Rate of histological clearance of the nBCC
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de octubre de 2024
Finalización primaria (Estimado)
1 de febrero de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
22 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2026
Publicado por primera vez (Actual)
26 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- P01-CLIN01
- ACTRN12624001138572 (Otro identificador: ANZCTR)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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