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Phase I-II

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

  • Study HIC#:2000041766
  • Last Updated:04/08/2026

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.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Priscilla Stéve

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    Trial Purpose and Description

    This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.

    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.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: