NCT07226349From ClinicalTrials.govRecruiting

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

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

Advanced Solid Tumor

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: BeOne Medicines
Enrolment target: 105
Started: 11 December 2025
Main results due: 1 November 2028
Study sites: 23
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(23)

University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Recruiting
City of Hope National Medical Center
Duarte, California, United States
Recruiting
Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Recruiting
Next Oncology Houston
Houston, Texas, United States
Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Recruiting
Genesiscare St Leonards
St Leonards, New South Wales, Australia
Recruiting
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Recruiting
One Clinical Research
Nedlands, Western Australia, Australia
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China
Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Recruiting
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
Wuhan, Hubei, China
Recruiting
Jiangsu Province Hospital Longjiang Branch
Nanjing, Jiangsu, China
Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, China
Recruiting
Weifang Peoples Hospital
Weifang, Shandong, China
Recruiting
Rigshospitalet
Copenhagen, Denmark
Recruiting

Showing 23 of 23 sites. 23 of the 23 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07226349. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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