Идёт набор NCT07284186

First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors

Фаза I С лечением Esophageal Squamous Cell Carcinoma Gastric Adenocarcinoma Gastric Squamous Cell Carcinoma Gastroesophageal Junction (GEJ) Adenocarcinoma

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: PLX-61639.
Кому может быть актуально: Состояния в реестре: Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastric Squamous Cell Carcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma. 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 Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors

Обзор

A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed/refractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies. The study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase. Participants will receive their assigned dose of PLX-61639 administered orally, once daily until progression/relapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.

Вмешательства

Препарат PLX-61639
Orally available degrader of SMARCA2

Первичные конечные точки

Treatment Emergent Adverse Events [Срок оценки: From enrollment to 28 days after the last dose of PLX-61639]
Dose-Limiting Toxicities [Срок оценки: From enrollment to 28 days after first dose of PLX-61639]

Вторичные конечные точки (9)

Dose reductions due to Adverse Events [Срок оценки: From Day 1 to the end of PLX-61639 treatment, an average of 1 year]
Study treatment discontinuations for reasons other than disease progression [Срок оценки: From Day 1 to the end of PLX-61639 treatment, an average of 1 year]
Pharmacokinetics of PLX-61639: Cmax [Срок оценки: From Day 1 to Day 15 of Cycle 1 (Part 1 only) (each cycle is 28 days)]
Pharmacokinetics of PLX-61639: Tmax [Срок оценки: From Day 1 to Day 15 of Cycle 1 (Part 1 only) (each cycle is 28 days)]
Pharmacokinetics of PLX-61639: AUC0-last [Срок оценки: From Day 1 to Day 16 of Cycle 1 (Part 1 only) (each cycle is 28 days)]
Radiographic response to PLX-61639 [Срок оценки: From Day 1 to the end of PLX-61639 treatment, an average of 1 year]
Time to response (TTR) to PLX-61639 [Срок оценки: From Day 1 to achievement of partial or complete response, up to 24 weeks]
Duration of response (DoR) to PLX-61639 [Срок оценки: From first documented partial or complete response to disease progression or death, an average of 1 year]
Progression Free Survival (PFS) of PLX-61639 [Срок оценки: From Day 1 to disease progression or death, an average of 1 year]

Критерии участия

Критерии включения

Participants with locally advanced or metastatic, relapsed/refractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies
Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function
Measurable disease per RECIST 1.1
ECOG PS of 0 or 1