Testing BG-75098 alone and with other drugs 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

This will test whether BG-75098, alone or combined with BGB-43395 or fulvestrant, is safe and shows activity in adults with advanced solid tumors who have had prior standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeOne Medicines (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 16 sites (Birmingham, Alabama and 15 other locations)
• Trial ID: NCT07226349 on ClinicalTrials.gov

What this trial studies

This Phase 1 study uses a dose-escalation (Phase 1a) then dose-expansion (Phase 1b) design to find safe dose ranges and early signs of anti-tumor effect for BG-75098 given alone and with BGB-43395 or fulvestrant. Primary goals are to characterize safety, tolerability, pharmacokinetics, and pharmacodynamics, with secondary assessment of preliminary antitumor activity by RECIST v1.1. Eligible participants have measurable advanced or metastatic unresectable solid tumors, ECOG performance status 0–1, and adequate organ function, with some cohorts enriched for tumors potentially dependent on CDK2. Treatment and monitoring occur at specialized cancer centers with frequent visits for dosing, safety labs, and imaging.

Who should consider this trial

Good fit: Adults with measurable advanced, metastatic, or unresectable solid tumors who have ECOG 0–1, adequate organ function, and prior standard systemic therapy (or no available standard options), with some cohorts specifically for tumors potentially CDK2-dependent.

Not a fit: Patients with poor performance status, inadequate organ function, readily available effective standard treatments, or tumors unlikely to be CDK2-dependent may not receive benefit from this early-phase trial.

Why it matters

Potential benefit: If successful, the regimen could offer a new targeted therapy option for patients with CDK2-related advanced solid tumors that might shrink tumors or slow disease progression.

How similar studies have performed: While CDK4/6 inhibitors have proven benefit in some cancers, CDK2-targeted degraders like BG-75098 represent a novel approach with limited prior clinical data so far.

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.

Where this trial is running

Birmingham, Alabama and 15 other locations

• University of Alabama At Birmingham Hospital — Birmingham, Alabama, United States (Recruiting)
• Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Next Houston — Houston, Texas, United States (Recruiting)
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (Recruiting)
• Icon Cancer Centre Wesley — Auchenflower, Queensland, Australia (Recruiting)
• Cabrini Hospital Malvern — Malvern East, Victoria, Australia (Recruiting)
• Peter Maccallum Cancer Centre — Melbourne, Victoria, 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)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Weifang Peoples Hospital — Weifang, Shandong, China (Recruiting)
• Rigshospitalet — Copenhagen, Denmark (Recruiting)

Study contacts

• Study coordinator: Study Director

Conditions Advanced Solid Tumor; Cyclin-Dependent Kinase 2- Targeted Protein Degrader; CDK2; CDK4; CDK4 inhibitor