Идёт набор NCT07498725

A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors

Фаза I / Фаза II С лечением Neoplasms

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: LRK-4189 escalation, LRK-4189 expansion, LRK-4189 optimization, Chemo.
Кому может быть актуально: Состояния в реестре: Neoplasms. Базовые параметры: от 18 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: Франция, Великобритания
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 1b-2, Open-Label, Dose-Escalation, Expansion and Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of LRK-4189 Alone and in Combination With mFOLFOX6 or FOLFIRI in Patients With Solid Tumors

Обзор

The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189. The main questions it aims to answer are: Is LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors? Participants will: * Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years. * Visit the clinic once every week for checkups and tests.

Вмешательства

Препарат LRK-4189 escalation
LRK-4189 at various doses
Препарат LRK-4189 expansion
LRK-4189 MTD
Препарат LRK-4189 optimization
LRK-4189 2 distinct doses
Препарат Chemo
Standard of care

Первичные конечные точки

Evaluation of treatment-related adverse events and/or toxicity, presented by dose, regimen and tumor type [Срок оценки: From enrollment to the end of the first treatment cycle (each cycle is 21 days)]

Критерии участия

Критерии включения

Willing and able to sign the study consent form and take part in all required study visits, tests, and procedures.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Have a locally advanced or metastatic cancer that cannot be removed with surgery and has gotten worse despite treatment.
Cancer can be measured on scans, such as CT or MRI.
Willing to have tumor biopsies, meaning small samples of your tumor will be collected during the study.
Heart rhythm test (ECG) shows a normal result within safe limits.
Blood test results at screening are within an acceptable and stable range.
If you are a woman, you are not able to become pregnant, or you agree not to become pregnant during the study and to use approved birth control methods.
If you are a man, you agree not to donate sperm during the study. If you have sex with a partner who could become pregnant, you agree to use approved birth control methods during the study.

Критерии исключения

Unable to swallow the study medication or your body cannot absorb it.
Have had a serious allergic reaction to LRK-4189 or any of its ingredients.
Have needed a fluid drainage procedure from the chest or abdomen within the past 6 weeks.
Have active cancer in the brain or spinal fluid, or brain tumors that require steroid treatment.
Currently receiving another cancer treatment.
Have an active HIV, hepatitis B, or hepatitis C infection with detectable virus levels.
Have an active infection that requires treatment through a vein (IV).
Taking certain medications that strongly interact with the study drug and cannot stop them at least 14 days before starting the study.
Pregnant or breastfeeding or planning to become pregnant or father a child during the study.
Cannot safely receive the standard chemotherapy that would be used with this study.

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

Здоровые добровольцы: Нет