A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT07226349
- Run by
- BeOne Medicines
- People needed
- 105
- Starts
- 2025-12-11
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Alabama At Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Sidney Kimmel Comprehensive Cancer At Johns Hopkins — Baltimore, Maryland, United States (enrolling)
- The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Next Houston — Houston, Texas, United States (enrolling)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
- Genesiscare St Leonards — St Leonards, New South Wales, Australia (enrolling)
- Icon Cancer Centre Wesley — Auchenflower, Queensland, Australia (enrolling)
- Cabrini Hospital Malvern — Malvern, Victoria, Australia (enrolling)
- Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
- One Clinical Research — Nedlands, Western Australia, Australia (enrolling)
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou, Guangdong, China (enrolling)
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
- Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch — Wuhan, Hubei, China (enrolling)
- Jiangsu Province Hospital Longjiang Branch — Nanjing, Jiangsu, China (enrolling)
- Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
- Weifang Peoples Hospital — Weifang, Shandong, China (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.