Идёт набор NCT07214662

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

Фаза I С лечением 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: GDC-0587, Giredestrant, Omeprazole.
Кому может быть актуально: Состояния в реестре: 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, Тайвань
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 Ia/Ib Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Patients With Locally Advanced Or Metastatic ER-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After CDK4/6 Inhibitor Therapy

Обзор

This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 \[CDK4\] inhibitor) as a monotherapy and in combination with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer who have previously progressed during or after CDK 4/6 inhibitor therapy.

Вмешательства

Препарат GDC-0587
Participants will receive GDC-0587 orally as per the schedule in the protocol.
Препарат Giredestrant
Participants will receive Giredestrant orally as per the schedule in the protocol.
Препарат Omeprazole
Participants will receive Omeprazole orally as per the schedule in the protocol.

Первичные конечные точки

Percentage of Participants with Adverse Events [Срок оценки: From Baseline to 30 days after final dose of study treatment (Up to approximately to 18 months)]
Percentage of Participants with Dose-limiting Toxicity (DLTs) [Срок оценки: Phase 1a: Days 1-28 of Cycle 1; Phase 1b: Days 1-28 of Cycle 1 (Each cycle is 28 days)]

Вторичные конечные точки (6)

Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [Срок оценки: Up to approximately to 18 months]
Plasma Concentration of GDC-0587 as a Monotherapy and in Combination With Giredestrant [Срок оценки: Phase 1a: Cycle 1 (Day 1, 2 15, 16), Cycle 2, 3, 5, 7, 9, 11 (Day 1); Phase 1b: Cycle 1 (Day 1, 2 15, 16), Cycle 2, 3, 5, 7, 9, 11 (Day 1) (Each cycle is 28 days)]
Plasma Concentration of GDC-0587 with Giredestrant Under Fasted and Fed Conditions [Срок оценки: Part 1b: Cycle 1 (Day 1, 2, 4), Cycle 2, 3, 5, 7, 9 and 11 (Day 1) (Each cycle is 28 days)]
Plasma Concentration of GDC-0587 with Giredestrant Following Multiple-dose Administration, Either Alone or in Combination With Omeprazole [Срок оценки: Part 1b: Cycle 1 (Day 11, 12, 20 and 21) (Each cycle is 28 days)]
Recommended Phase II Dose (RP2D) of GDC-0587 [Срок оценки: Up to approximately to 18 months]
Recommended Phase II Dose (RP2D) of GDC-0587 in Combination with Giredestrant [Срок оценки: Up to approximately to 18 months]

Критерии участия

Критерии включения

Agreement to adhere to the contraception requirements
For females of childbearing potential ≤60 years of age and males: treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Cycle 1, Day 1 and agreement to continue LHRH agonist therapy for the duration of the study
Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic
Previously documented ER+ and HER2- tumor according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines
Disease progression during or following treatment with an approved CDK 4/6 inhibitor, with or without endocrine therapy, in the locally advanced or metastatic setting
Measurable, or non-measurable but evaluable, disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy ≥6 months
Creatinine clearance ≥60 milliliter per minute (mL/min) (calculated through use of the Cockcroft-Gault formula)

Критерии исключения

Pregnant or breastfeeding, or intention of becoming pregnant during the study
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines
Five or more prior lines of systemic therapy in the locally advanced or metastatic setting
Treatment with anti-cancer therapies, including investigational therapies, within 28 days or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study drug
Treatment with an approved oral endocrine therapy within 7 days prior to initiation of study drug or treatment with fulvestrant or an approved/investigational CDK inhibitor within 21 days prior to initiation of study drug
History of Grade ≥3 adverse event attributed to prior CDK inhibitor therapy that resulted in permanent discontinuation of prior CDK inhibitor therapy
Poor peripheral venous access
Malabsorption condition or other gastrointestinal (GI) conditions/surgeries that the investigator assesses may significantly interfere with enteral absorption
Major surgical procedure within 28 days prior to initiation of study drug
Untreated, active CNS metastases
Infection requiring systemic (i.e., oral, IV, or intramuscular) antibiotics, chronic infection requiring treatment within 1 year prior to screening, or any evidence of current infection
History of malignancy within 3 years prior to screening, except for cancer under investigation in this study
Known history of a clinically significant abnormal ECG

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

Здоровые добровольцы: Нет