此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年6月25日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

48

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 澳大利亚
    • Australian Capital Territory
      • Phillip、Australian Capital Territory、澳大利亚、2606
        • 招聘中
        • Woden Dermatology
    • New South Wales
      • Charlestown、New South Wales、澳大利亚、2290
        • 招聘中
        • Novatrials
      • Randwick、New South Wales、澳大利亚、2031
        • 招聘中
        • Scientia Clinical Research
      • Waitara、New South Wales、澳大利亚、2077
        • 招聘中
        • Innovate Clinical Research
    • Queensland
      • Westcourt、Queensland、澳大利亚、4870
        • 招聘中
        • FNQH Cairns Skin Cancer Clinic
      • Woolloongabba、Queensland、澳大利亚、4102
        • 招聘中
        • Veracity Clinical Research
      • Woolloongabba、Queensland、澳大利亚、4102
        • 招聘中
        • Translational Research Institute
  • 美国
    • Kentucky
      • Bowling Green、Kentucky、美国、42104
        • 招聘中
        • Equity Medical
    • New York
      • New York、New York、美国、10023
        • 尚未招聘
        • Equity Medical

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：SAD Dose 1
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：SAD Dose 2
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：SAD Dose 3
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：SAD Dose 4
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：MAD Dose 1
A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：MAD Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：MAD Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：MAD Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：MAD-FV Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：MAD-FV Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
实验性的：MAD-FV Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
药品：Intralesional FLD-103
Intralesional and perilesional injection of FLD-103

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
大体时间：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
大体时间：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)

次要结果测量

结果测量
大体时间
Maximum observed concentration (Cmax)
大体时间：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)
大体时间：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)
大体时间：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)

其他结果措施

结果测量
大体时间
Rate of histological clearance of the nBCC
大体时间：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)
大体时间：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)
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Feldan Therapeutics

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月30日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月26日

研究记录更新

最后更新发布 (实际的)

2026年6月29日

上次提交的符合 QC 标准的更新

2026年6月25日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • P01-CLIN01
  • ACTRN12624001138572 (其他标识符：ANZCTR)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅