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

Официальное название

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

Обзор

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.

Вмешательства

• Препарат BG-75202
  Administered orally.
• Препарат CDK4 Inhibitor
  Administered orally.
• Препарат Estrogen Receptor Antagonist
  Administered by intramuscular injection.
• Препарат Aromatase Inhibitor
  Administered orally.

Первичные конечные точки

• Part 1: Number of Participants with Adverse Events (AEs) [Срок оценки: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 12 months]
• Part 1: Recommended Dose for Expansion (RDFE) [Срок оценки: Estimated approximately 1 year]
• Part 2: Overall Response Rate (ORR) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (12)

• Part 1: ORR [Срок оценки: Up to approximately 1 year]
• Part 1: Duration of Response (DOR) [Срок оценки: Up to approximately 1 year]
• Part 1: Time to Response (TTR) [Срок оценки: Up to approximately 1 year]
• Part 2: DOR [Срок оценки: Up to approximately 2 years]
• Part 2: TTR [Срок оценки: Up to approximately 2 years]
• Part 2: Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
• Part 2: Clinical Benefit Rate (CBR) [Срок оценки: Up to approximately 2 years]
• Part 2: Progression-Free Survival (PFS) [Срок оценки: Up to approximately 2 years]
• Part 2: Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 2 years]
• Part 2: Recommended Phase 2 Dose (RP2D) [Срок оценки: Up to approximately 2 years]
• Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of BG-75202 [Срок оценки: Up to approximately 4 months]
• Parts 1 and 2: Minimum Observed Plasma Concentration (Ctrough) of BG-75202 [Срок оценки: Up to approximately 4 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 10 центров

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Beijing Cancer Hospital — Пекин
• Chongqing University Cancer Hospital — Чунцин
• The First Affiliated Hospital of Xiamen University — Xiamen
• Sun Yat Sen University Cancer Center Huangpu Branch — Гуанчжоу
• Harbin Medical University Cancer Hospital — Харбин
• Jiangsu Province Hospital Longjiang Branch — Нанкин
• Fudan University Shanghai Cancer Centerpudong — Шанхай
• … и ещё 2 центра

США · 6 центров

• University of Alabama At Birmingham Hospital — Birmingham
• Yale Cancer Center — New Haven
• Washington University in St Louis — St Louis
• Next Oncology Austin — Austin
• The University of Texas Md Anderson Cancer Center — Houston
• Fred Hutchinson Cancer Research Center — Seattle

Австралия · 5 центров

• Blacktown Cancer and Haematology Centre — Blacktown
• Chris Obrien Lifehouse — Camperdown
• Cancer Research South Australia — Adelaide
• Austin Health — Heidelberg
• Peter Maccallum Cancer Centre — Melbourne

Испания · 5 центров

• Hospital Universitario Vall Dhebron — Barcelona
• Next Oncology Barcelona — Barcelona
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Clinico San Carlos — Madrid
• Hospital Universitario Virgen de La Victoria — Málaga

Италия · 4 центра

• Istituto Europeo Di Oncologia — Milan
• Istituto Nazionale Tumori Fondazione G Pascale — Naples
• Fondazione Policlinico Universitario Agostino Gemelli — Roma
• Istituto Clinico Humanitas — Rozzano

Идентификаторы

NCT: NCT07222267 · BG-75202-101 · 2025-523553-34-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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