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Набира участници Фаза 1 NCT07222267

An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Breast Cancer Advanced Solid Tumor

Спонсор: BeOne Medicines

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A/B inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.
Кой може да участва
Inclusion Criteria: * Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and/or without available standard of care therapies. * Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced/ metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload). * Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are not approved and/or not available as the first-line treatment and who are CDK4/6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease. * Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment. * Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate organ function. Exclusion Criteria: * Prior exposure to KAT6A/B or KAT7 inhibitors/degraders. * Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis. * Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Интервенции
BG-75202
DRUG
CDK4 Inhibitor
DRUG
Estrogen Receptor Antagonist
DRUG
Aromatase Inhibitor
DRUG
Места на провеждане 23
Австралия (4)
Cancer Research South Australia
Adelaide , South Australia
Blacktown Cancer and Haematology Centre
Blacktown , New South Wales
Chris Obrien Lifehouse
Camperdown , New South Wales
Peter Maccallum Cancer Centre
Melbourne , Victoria
Китай (7)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing , Beijing Municipality
Beijing Cancer Hospital
Beijing , Beijing Municipality
Sun Yat Sen University Cancer Centerhuangpu Branch
Guangzhou , Guangdong
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
Jiangsu Province Hospital Longjiang Branch
Nanjing , Jiangsu
Fudan University Shanghai Cancer Centerpudong
Shanghai , Shanghai Municipality
Tianjin Medical University Cancer Institute and Hospital
Tianjin , Tianjin Municipality
Италия (3)
Istituto Europeo Di Oncologia
Milan
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Istituto Clinico Humanitas
Rozzano
Испания (4)
Next Oncology Barcelona
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Universitario Virgen de La Victoria
Málaga
САЩ (5)
Next Oncology Austin
Austin , Texas
University of Alabama At Birmingham Hospital
Birmingham , Alabama
The University of Texas Md Anderson Cancer Center
Houston , Texas
Yale Cancer Center
New Haven , Connecticut
Washington University in St Louis
St Louis , Missouri
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
11.12.2025
Крайна дата
13.01.2037
Регистрационен номер
NCT07222267
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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