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NCT07226349PHASE1Recruiting

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

BeOne Medicines

Start Date

12/11/2025

Completion Date

11/1/2028

Summary

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.

Detailed Description

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interventions

DRUG

BG-75098

DRUG

BGB-43395

DRUG

Fulvestrant

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Conditions

Advanced Solid Tumor

Locations

University of Alabama At Birmingham Hospital

Birmingham, Alabama 35294-0004

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Sidney Kimmel Comprehensive Cancer At Johns Hopkins

Baltimore, Maryland 21287

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Next Houston

Houston, Texas 77054

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226-3522

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Genesiscare St Leonards

St Leonards, New South Wales NSW 2065

Australia

Icon Cancer Centre Wesley

Auchenflower, Queensland QLD 4066

Australia

Cabrini Hospital Malvern

Malvern, Victoria VIC 3144

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria VIC 3000

Australia

One Clinical Research

Nedlands, Western Australia WA 6009

Australia

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality 100021

China

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

Guangzhou, Guangdong 510245

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430030

China

Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch

Wuhan, Hubei 430048

China

Jiangsu Province Hospital Longjiang Branch

Nanjing, Jiangsu 210036

China

Qilu Hospital of Shandong University

Jinan, Shandong 250000

China

Weifang Peoples Hospital

Weifang, Shandong 261000

China

Rigshospitalet

Copenhagen, 2100

Denmark