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

2026년 6월 25일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

48

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Kentucky
      • Bowling Green, Kentucky, 미국, 42104
        • 모병
        • Equity Medical
    • New York
      • New York, New York, 미국, 10023
        • 아직 모집하지 않음
        • Equity Medical
  • 호주
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, 호주, 2606
        • 모병
        • Woden Dermatology
    • New South Wales
      • Charlestown, New South Wales, 호주, 2290
        • 모병
        • Novatrials
      • Randwick, New South Wales, 호주, 2031
        • 모병
        • Scientia Clinical Research
      • Waitara, New South Wales, 호주, 2077
        • 모병
        • Innovate Clinical Research
    • Queensland
      • Westcourt, Queensland, 호주, 4870
        • 모병
        • FNQH Cairns Skin Cancer Clinic
      • Woolloongabba, Queensland, 호주, 4102
        • 모병
        • Veracity Clinical Research
      • Woolloongabba, Queensland, 호주, 4102
        • 모병
        • Translational Research Institute

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: SAD Dose 1
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: SAD Dose 2
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: SAD Dose 3
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: SAD Dose 4
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: MAD Dose 1
A multiple doses of FLD-103 0.5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: MAD Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: MAD Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: MAD Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks (lesion size-determined volume).
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: MAD-FV Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: MAD-FV Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103
실험적: MAD-FV Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
의약품: Intralesional FLD-103
Intralesional and perilesional injection of FLD-103

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
기간: 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
기간: 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)

2차 결과 측정

결과 측정
기간
Maximum observed concentration (Cmax)
기간: 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)
기간: 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)
기간: 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)

기타 결과 측정

결과 측정
기간
Rate of histological clearance of the nBCC
기간: 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)
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Feldan Therapeutics

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 10월 30일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2026년 6월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 22일

처음 게시됨 (실제)

2026년 6월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 25일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • P01-CLIN01
  • ACTRN12624001138572 (기타 식별자: ANZCTR)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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