Набор скоро начнётся NCT07336771

JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer

Фаза I / Фаза II С лечением Metastatic Breast Cancer Locally Advanced Breast Cancer (LABC)

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: JSKN016 Q2W, JSKN016 Q3W, D-0502.
Кому может быть актуально: Состояния в реестре: Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC). 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: 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 Multicenter, Open-Label, Phase Ib/II Randomized Study of JSKN016 in Combination With D-0502 in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer

Обзор

This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously progressed on CDK4/6 inhibitor-based endocrine therapy. Approximately 60 patients will be randomized in a 1:1 ratio to receive JSKN016 administered intravenously every 2 weeks (Q2W) or every 3 weeks (Q3W), in combination with daily oral D-0502. Each dosing cohort will include a safety lead-in phase to assess DLTs prior to cohort expansion. Tumor response will be assessed according to RECIST v1.1.

Вмешательства

Препарат JSKN016 Q2W
4 mg/kg, intravenous infusion, every 2 weeks
Препарат JSKN016 Q3W
4 mg/kg, intravenous infusion, every 3 weeks
Препарат D-0502
200 mg, oral, once daily

Первичные конечные точки

Incidence of dose-limiting toxicities (DLTs) [Срок оценки: From first dose through the end of Cycle 1 (approximately 21 days)]
Objective Response Rate (ORR) [Срок оценки: From first dose through treatment discontinuation, assessed up to 12 months]
Safety and tolerability (TEAEs, TRAEs, SAEs) [Срок оценки: From first dose until 30 days after the last dose of study treatment.]

Вторичные конечные точки (5)

Disease Control Rate (DCR) [Срок оценки: From first dose through 24 weeks]
Duration of Response (DoR) [Срок оценки: From first documented objective response (CR or PR) until disease progression or death, whichever occurs first, assessed up to 24 months]
Clinical Benefit Rate (CBR) [Срок оценки: From first dose through 24 weeks]
Progression-Free Survival (PFS) [Срок оценки: From first dose until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months]
Overall Survival (OS) [Срок оценки: From first dose until death from any cause, assessed up to 36 months]

Критерии участия

Критерии включения

Age ≥18 years
Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer
HR-positive defined as ER and/or PR ≥1% by IHC
HER2-negative per ASCO/CAP guidelines
At least one measurable extracranial lesion per RECIST v1.1
ECOG performance status 0-1
Prior progression on CDK4/6 inhibitor plus endocrine therapy
Adequate organ and cardiac function
Postmenopausal women, or premenopausal women receiving ovarian function suppression