Testing BG-75098 alone and with other drugs in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 8778285568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.