Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)
25 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
48
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Catherine Lippé
- Número de telefone: 1 581-397-8597
- E-mail: clippe@feldan.com
Locais de estudo
-
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Australian Capital Territory
-
Phillip, Australian Capital Territory, Austrália, 2606
- Recrutamento
- Woden Dermatology
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New South Wales
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Charlestown, New South Wales, Austrália, 2290
- Recrutamento
- Novatrials
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Randwick, New South Wales, Austrália, 2031
- Recrutamento
- Scientia Clinical Research
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Waitara, New South Wales, Austrália, 2077
- Recrutamento
- Innovate Clinical Research
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Queensland
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Westcourt, Queensland, Austrália, 4870
- Recrutamento
- FNQH Cairns Skin Cancer Clinic
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Woolloongabba, Queensland, Austrália, 4102
- Recrutamento
- Veracity Clinical Research
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Woolloongabba, Queensland, Austrália, 4102
- Recrutamento
- Translational Research Institute
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Kentucky
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Bowling Green, Kentucky, Estados Unidos, 42104
- Recrutamento
- Equity Medical
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New York
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New York, New York, Estados Unidos, 10023
- Ainda não está recrutando
- Equity Medical
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Maximum observed concentration (Cmax)
Prazo: 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)
Prazo: 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)
Prazo: 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)
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
Rate of histological clearance of the nBCC
Prazo: 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)
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de outubro de 2024
Conclusão Primária (Estimado)
1 de fevereiro de 2027
Conclusão do estudo (Estimado)
1 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
22 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de junho de 2026
Primeira postagem (Real)
26 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- P01-CLIN01
- ACTRN12624001138572 (Outro identificador: ANZCTR)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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