Actively Recruiting
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
Eligibility Criteria
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.
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
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
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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