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.
調査の概要
研究の種類
介入
入学 (推定)
48
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Catherine Lippé
- 電話番号：1 581-397-8597
- メール：clippe@feldan.com
研究場所
-
-
Kentucky
-
Bowling Green、Kentucky、アメリカ、42104
- 募集
- Equity Medical
-
-
New York
-
New York、New York、アメリカ、10023
- まだ募集していません
- Equity Medical
-
-
-
-
Australian Capital Territory
-
Phillip、Australian Capital Territory、オーストラリア、2606
- 募集
- Woden Dermatology
-
-
New South Wales
-
Charlestown、New South Wales、オーストラリア、2290
- 募集
- Novatrials
-
Randwick、New South Wales、オーストラリア、2031
- 募集
- Scientia Clinical Research
-
Waitara、New South Wales、オーストラリア、2077
- 募集
- Innovate Clinical Research
-
-
Queensland
-
Westcourt、Queensland、オーストラリア、4870
- 募集
- FNQH Cairns Skin Cancer Clinic
-
Woolloongabba、Queensland、オーストラリア、4102
- 募集
- Veracity Clinical Research
-
Woolloongabba、Queensland、オーストラリア、4102
- 募集
- Translational Research Institute
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：SAD Dose 1
A single dose of FLD-103 0.5 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
実験的：SAD Dose 2
A single dose of FLD-103 1 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
実験的：SAD Dose 3
A single dose of FLD-103 3 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
実験的：SAD Dose 4
A single dose of FLD-103 5 mg/mL (lesion size-determined volume)
|
Intralesional and perilesional injection of FLD-103
|
|
実験的：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
|
|
実験的：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
|
|
実験的：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
|
|
実験的：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
|
|
実験的：MAD-FV Dose 2
A multiple doses of FLD-103 1 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
|
Intralesional and perilesional injection of FLD-103
|
|
実験的：MAD-FV Dose 3
A multiple doses of FLD-103 3 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
|
Intralesional and perilesional injection of FLD-103
|
|
実験的：MAD-FV Dose 4
A multiple doses of FLD-103 5 mg/mL once weekly for four (4) weeks with a fixed volume (FV).
|
Intralesional and perilesional injection of FLD-103
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs)
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Maximum observed concentration (Cmax)
時間枠：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)
時間枠：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)
時間枠：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)
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Rate of histological clearance of the nBCC
時間枠：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)
時間枠：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)
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年10月30日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年6月22日
QC基準を満たした最初の提出物
2026年6月22日
最初の投稿 (実際)
2026年6月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月29日
QC基準を満たした最後の更新が送信されました
2026年6月25日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。