A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
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: KST-6051.
- Кому может быть актуально
- Состояния в реестре: KRAS-mutant Non-small Cell Lung Cancer (NSCLC), KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC), KRAS-mutant Colorectal Cancer (CRC), Other KRAS-mutant Solid Tumors. 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
- США
- 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 First-in-human Phase 1 Dose-escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation
Обзор
The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally to adults with advanced or metastatic solid tumors with certain KRAS mutations.
Подробное описание
This is a first-in-human, phase 1, open-label, multicenter clinical trial designed to evaluate safety, tolerability, pharmacokinetics, biomarkers, pharmacodynamics and preliminary activity of orally administered KST-6051. The trial seeks to enroll adults with advanced or metastatic KRAS mutant solid tumors including but not limited to pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer whose cancers have progressed after prior therapy or in whom standard therapy was not tolerated. The trial includes a dose escalation phase in which higher doses of KST-6051 will be given in subsequent groups of participants. Participants can stay in the trial as long as they benefit from the treatment and can tolerate it.
Вмешательства
- Препарат KST-6051
KST-6051 will be administered orally as a tablet.
Первичные конечные точки
- Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days) [Срок оценки: Up to Day 21 of Treatment Cycle 1]
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 2 years]
- Number of Participants With Treatment-related Adverse Events (TRAEs) [Срок оценки: Up to approximately 2 years]
Вторичные конечные точки (9)
- Maximum Observed Blood Concentration (Cmax) of KST-6051 [Срок оценки: Up to Week 6]
- Time to Achieve Cmax (Tmax) of KST-6051 [Срок оценки: Up to Week 6]
- Half-life (t1/2) of KST-6051 [Срок оценки: Up to Week 6]
- Area Under the Blood Concentration-time Curve (AUC) of KST-6051 [Срок оценки: Up to Week 6]
- Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years]
- Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
- Duration of Overall Response (DOR) [Срок оценки: Up to approximately 2 years]
- Progression-free Survival (PFS) [Срок оценки: Up to approximately 2 years]
- Duration of Stable Disease [Срок оценки: Up to approximately 2 years]
Критерии участия
Критерии включения
- Age ≥ 18 years.
- Willing and able to give written informed consent.
- Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor.
- Documentation of KRAS mutation prior to the first dose of trial drug(s).
- Progressed on or intolerant to standard treatment(s).
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Adequate cardiovascular, hematological, liver, and renal function.
- Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
Критерии исключения
- Previous or current treatment with RAS or KRAS inhibitors.
- Central nervous system (CNS) tumors or metastases.
- Inability to swallow oral medications.
- Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
Other inclusion/exclusion criteria are specified in the protocol.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 9 центров
- Cedars-Sinai Medical Center — Los Angeles
- Florida Cancer Specialists — Sarasota
- Moffitt Cancer Center — Tampa
- Mass General Brigham Cancer Institute at Massachusetts General Hospital — Boston
- Sidney Kimmel Cancer Center — Philadelphia
- The University of Texas MD Anderson Cancer Center — Houston
- NEXT Oncology — San Antonio
- Huntsman Cancer Institute, University of Utah — Salt Lake City
- … и ещё 1 центр
Идентификаторы
NCT: NCT07458347 · KST-6051-101