Идёт набор NCT06463340

Study of SGR-3515 In Participants With Advanced Solid Tumors.

Фаза I С лечением Advanced Solid Tumor

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: SGR-3515.
Кому может быть актуально: Состояния в реестре: Advanced Solid Tumor. 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, Канада
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 of SGR-3515 In Participants With Advanced Solid Tumors.

Обзор

The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced solid tumors.

Подробное описание

SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1/Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.

Вмешательства

Препарат SGR-3515
SGR-3515 will be administered orally with an intermittent schedule.

Первичные конечные точки

Incidence and severity of adverse events (AEs) [Срок оценки: Day 1 to 28 days after the last dose of SGR-3515.]
Incidence of Dose Limiting Toxicities (DLTs) [Срок оценки: Day 1 to Day 28 of the first 28-day dosing cycle.]
Incidence of serious adverse events (SAEs) [Срок оценки: Day 1 to 28 days after the last dose of SGR-3515]
Recommended phase 2 dose and schedule [Срок оценки: From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.]

Вторичные конечные точки (5)

Pharmacokinetics: Measures Cmax and Cmin of SGR-3515 [Срок оценки: Day 1 to Day 28 of first 28-day dosing cycle]
Pharmacokinetics Measures: t1/2 of SGR-3515 [Срок оценки: Day 1 to Day 28 of first 28-day dosing cycle]
Pharmacokinetics Measures: tmax of SGR-3515 [Срок оценки: Day 1 to Day 28 of first 28-day dosing cycle]
Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515 [Срок оценки: Day 1 to Day 28 of first 28-day dosing cycle]
Efficacy analysis [Срок оценки: Day 1 to end of Phase I study]

Критерии участия

Критерии включения

Diagnosis of advanced/metastatic solid tumor
Measurable disease per RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
Adequate bone marrow and organ function
Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug

Критерии исключения

Participants with primary Central Nervous System (CNS tumors).
Participant has received prior systemic anti-cancer treatments or other investigational agents ≤ 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
Participant who has received definitive local control radiation (any dose greater than 50 Gy) < 42 days prior to the first dose of study drug.
Participant who has received major surgeries ≤ 21 days prior to first dose of study drug
Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
Participant who has another clinically significant invasive malignancy, as determined by the investigator, ≤ 2 years prior to the first dose

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

Здоровые добровольцы: Нет