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

ConditionAdvanced Solid Tumor

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorBeOne Medicines

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.