Идёт набор NCT07670858

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

Фаза I С лечением Nodular Basal Cell Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Intralesional FLD-103.
Кому может быть актуально: Состояния в реестре: Nodular Basal Cell Carcinoma. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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).

Обзор

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.

Вмешательства

Препарат Intralesional FLD-103
Intralesional and perilesional injection of FLD-103

Первичные конечные точки

Frequency, severity and relationship of Treatment Emergent Adverse events (TEAEs) [Срок оценки: 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 [Срок оценки: From enrollment until the end-of-study (EOS) visit (up to Day 36 for SAD / up to Day 57 for MAD/MAD-FV)]

Вторичные конечные точки (3)

Maximum observed concentration (Cmax) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From enrollment until the end of treatment (EOT) (up to Day 8 for SAD / up to Day 36 for MAD/MAD-FV)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет