Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07226349

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

Led by BeOne Medicines · Updated on 2026-05-11

105

Participants Needed

16

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 confirmed advanced, metastatic, or unresectable solid tumors possibly related to cyclin-dependent kinase 2 (CDK2) dependency.
  • Participants should have received prior standard-of-care systemic therapies or have no available or tolerated standard therapy.
  • Dose Escalation Part B: Participants with confirmed advanced, metastatic, or unresectable solid tumors who have received at least 1 prior line of systemic therapy in the metastatic setting.
  • Dose Expansion Cohort 1: Participants with confirmed advanced, metastatic, or unresectable CDK4/6 inhibitor-progressed solid tumors.
  • Dose Expansion Cohort 2: Participants with advanced solid tumors who have received at least 1 line of platinum-containing chemotherapy and no more than 4 prior therapeutic regimens in the advanced/metastatic setting.
  • Participants with primary platinum refractory disease are not eligible.
Not Eligible

You will not qualify if you...

  • Prior therapy selectively targeting CDK2 inhibition or degradation.
  • For combination cohorts: Prior therapy selectively targeting CDK4 is not allowed.
  • Prior CDK4/6 inhibitor standard of care therapy is permitted where approved and available.
  • Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  • Other protocol-defined inclusion/exclusion criteria may apply.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

University of Alabama At Birmingham Hospital

Birmingham, Alabama, United States, 35294-0004

Actively Recruiting

2

Yale Cancer Center

New Haven, Connecticut, United States, 06510

Actively Recruiting

3

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States, 77030-4009

Actively Recruiting

4

Next Houston

Houston, Texas, United States, 77054

Actively Recruiting

5

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia, NSW 2148

Actively Recruiting

6

Icon Cancer Centre Wesley

Auchenflower, Queensland, Australia, QLD 4066

Actively Recruiting

7

Cabrini Hospital Malvern

Malvern East, Victoria, Australia, VIC 3144

Actively Recruiting

8

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, VIC 3000

Actively Recruiting

9

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

10

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

Guangzhou, Guangdong, China, 510245

Actively Recruiting

11

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

12

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

Wuhan, Hubei, China, 430030

Actively Recruiting

13

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

Wuhan, Hubei, China, 430048

Actively Recruiting

14

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250000

Actively Recruiting

15

Weifang Peoples Hospital

Weifang, Shandong, China, 261000

Actively Recruiting

16

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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