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

Drug
BG-75098
Administered orally.
Drug
BGB-43395
Administered orally.
Drug
Fulvestrant
Administered by intramuscular injection.

Locations (23)

University of Alabama At Birmingham Hospital
Birmingham, Alabama
City of Hope National Medical Center
Duarte, California
Yale Cancer Center
New Haven, Connecticut
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland
Massachusetts General Hospital
Boston, Massachusetts
The University of Texas Md Anderson Cancer Center
Houston, Texas