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
BeOne Medicines
Summary
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.
Description
This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, o…
Interventions
- DrugBG-75098
Administered orally.
- DrugBGB-43395
Administered orally.
- DrugFulvestrant
Administered by intramuscular injection.
Locations (16)
- University of Alabama At Birmingham HospitalBirmingham, Alabama
- Yale Cancer CenterNew Haven, Connecticut
- The University of Texas Md Anderson Cancer CenterHouston, Texas
- Next HoustonHouston, Texas
- Blacktown Cancer and Haematology CentreBlacktown, New South Wales
- Icon Cancer Centre WesleyAuchenflower, Queensland