Идёт набор NCT06993844

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

Фаза I / Фаза II С лечением Advanced Solid Tumors Advanced Breast Cancer

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: ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant.
Кому может быть актуально: Состояния в реестре: Advanced Solid Tumors, Advanced Breast Cancer. 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, Китай
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 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

Обзор

Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors

Подробное описание

Brief Summary: This is a Phase 1/2, open-label, multicenter, 3-part study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation.

Part A will evaluate escalating doses of ETX-636 as monotherapy in participants with advanced solid tumors. Part B will evaluate escalating doses of ETX-636 as combination therapy with fixed dose fulvestrant in participants with hormone receptor positive (HR+), HER2 negative (HER2-) locally advanced or metastatic breast cancer. Part C will be a combination therapy expansion in participants with HR+, HER2- locally advanced or metastatic breast cancer.

Each study part will include a 28-day screening period, followed by treatment with ETX-636 monotherapy or combination therapy.

Вмешательства

Препарат ETX-636 dose escalation
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet that will be taken once per day in 28-day cycles, to evaluate escalating dose levels.
Препарат ETX-636 dose escalation in combination with fulvestrant
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to evaluate escalating dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.
Препарат ETX-636 dose expansion in combination with fulvestrant
ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to expand selected dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.

Первичные конечные точки

Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B [Срок оценки: First 28 days of treatment]
Evaluate Safety and Tolerability of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B [Срок оценки: Average of 6 months]
Select the Recommended Phase 2 Dose(s) (RP2D) in Part B to be further explored in Part C (combination therapy expansion) [Срок оценки: Average of 6 months]
Evaluate efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C [Срок оценки: Average of 6 months]

Вторичные конечные точки (12)

Characterize the Cmax (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B [Срок оценки: First 2 treatment cycles (each cycle is 28 days)]
Characterize the Tmax (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B [Срок оценки: First 2 treatment cycles (each cycle is 28 days)]
Characterize the AUC (PK) of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B [Срок оценки: First 2 treatment cycles (each cycle is 28 days)]
Measure PD effects of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B and ETX-636 plus fulvestrant at the RP2D(s) in Part C [Срок оценки: First 3 cycles (each cycle is 28 days)]
Changes in fasting blood glucose (All Parts) [Срок оценки: Average of 6 months]
Changes in longitudinal glucose metabolism (All Parts) [Срок оценки: Average of 6 months]
Assess preliminary efficacy of ETX-636 monotherapy in Part A and ETX-636 plus fulvestrant combination therapy in Part B [Срок оценки: Average of 6 months]
Evaluate measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C [Срок оценки: Average of 6 months]
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C [Срок оценки: Average of 6 months]
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C [Срок оценки: Average of 6 months]
Evaluate additional measures of efficacy of ETX-636 plus fulvestrant combination therapy at the RP2D(s) in Part C [Срок оценки: Average of 6 months]
Evaluate Safety of ETX-636 plus fulvestrant combination therapy at the RP2Ds in Part C [Срок оценки: Average of 6 months]

Критерии участия

Критерии включения

Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.
Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.
At least 1 measurable lesion or evaluable disease per RECIST v1.1.
An ECOG performance status score of 0 or 1.
Adequate organ function.

Additional key inclusion criterion for Parts B and C:

\- Confirmed metastatic or locally advanced HR+/HER2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior CDK4/6 inhibitor and at least 1 prior anti-estrogen therapy.

Критерии исключения

Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.
Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.
Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.
Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.
Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.

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

Здоровые добровольцы: Нет