A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors

Официальное название

A Phase 1a/1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

Обзор

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.

Подробное описание

This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.

Вмешательства

• Препарат BG-75098
  Administered orally.
• Препарат BGB-43395
  Administered orally.
• Препарат Fulvestrant
  Administered by intramuscular injection.

Первичные конечные точки

• Phase 1a: Number of Participants with Adverse Events (AEs) [Срок оценки: From first dose to 30 days after last dose, up to approximately 12 months]
• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098 [Срок оценки: Up to approximately 2 years]
• Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-75098 as Monotherapy and in Combination with BGB-43395 and Fulvestrant [Срок оценки: Up to approximately 2 years]
• Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (12)

• Phase 1a: ORR as Assessed by the Investigator [Срок оценки: Up to approximately 2 years]
• Phase 1a: Duration of Response (DOR) as Assessed by the Investigator [Срок оценки: Up to approximately 2 years]
• Phase 1a: Time to Response (TTR) as Assessed by the Investigator [Срок оценки: Up to approximately 2 years]
• Phase 1a: Progression-Free Survival (PFS) as Assessed by the Investigator [Срок оценки: Up to approximately 2 years]
• Phase 1b: DOR as Assessed by the Investigator [Срок оценки: Up to approximately 2 years]
• Phase 1b: TTR as Assessed by the Investigator [Срок оценки: Up to approximately 2 years]
• Phase 1b: Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
• Phase 1b: Clinical Benefit Rate (CBR) [Срок оценки: Up to approximately 2 years]
• Phase 1b: PFS [Срок оценки: Up to approximately 2 years]
• Phase 1b: Number of Participants with AEs [Срок оценки: Up to approximately 2 years]
• Observed Plasma Maximum Concentration (Cmax) of BG-75098 [Срок оценки: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)]
• Observed Plasma Trough Concentration (Ctrough) of BG-75098 [Срок оценки: Assessed at select time points between Cycle 1 and Cycle 2 (each Cycle is 28 days)]

Критерии участия

Критерии включения

• Participants must have measurable disease as assessed by RECIST v1.1.
• Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants must have adequate organ function.
• Dose Escalation Part A: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors potentially associated with cyclin-dependent kinase 2 (CDK2) dependency. Participants should have received prior treatment with available standard-of-care (SOC) systemic therapies for advanced/metastatic disease, or for whom standard therapy is not available or not tolerated.
• Dose Escalation Part B: Patients with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who have received ≥ 1 prior line of systemic therapy in the metastatic setting.
• Dose Expansion Cohort 1: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable CDK4/6 inhibitor-progressed solid tumors.
• Dose Expansion Cohort 2: Participants with advanced solid tumors. Participants with primary platinum refractory disease are not eligible. Participants should have received ≥ 1 line of platinum-containing chemotherapy and ≤ 4 prior therapeutic regimens in the advanced/metastatic setting.

Критерии исключения

• For all cohorts: Prior therapy selectively targeting CDK2 inhibition or degradation.
• For combination cohorts: Prior therapy selectively targeting CDK4. Prior CDK4/6 inhibitor standard of care therapy is permitted and required in local regions where it is approved and available.
• Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.

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 · 8 центров

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Гуанчжоу
• Harbin Medical University Cancer Hospital — Харбин
• Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Ухань
• Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinh — Ухань
• Jiangsu Province Hospital Longjiang Branch — Нанкин
• Qilu Hospital of Shandong University — Цзинань
• Weifang Peoples Hospital — Weifang

США · 6 центров

• University of Alabama At Birmingham Hospital — Birmingham
• Yale Cancer Center — New Haven
• Sidney Kimmel Comprehensive Cancer At Johns Hopkins — Baltimore
• The University of Texas Md Anderson Cancer Center — Houston
• Next Houston — Houston
• Medical College of Wisconsin — Milwaukee

Австралия · 6 центров

• Blacktown Cancer and Haematology Centre — Blacktown
• Genesiscare St Leonards — St Leonards
• Icon Cancer Centre Wesley — Auchenflower
• Cabrini Hospital Malvern — Malvern
• Peter Maccallum Cancer Centre — Melbourne
• One Clinical Research — Nedlands

Дания · 1 центр

• Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT07226349 · BG-75098-101 · 2025-523165-19-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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