Summary
The purpose of this study is to evaluate how safe and tolerable a drug called BG-75098 is, as well as how it reacts within the body and what anti-cancer effect it has. BG-75098 will be evaluated both by itself, and in combination with other medicines (BGB-43395 and fulvestrant hormone therapy) in people with advanced solid cancers.
This study will be conducted in 2 phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion.
Phase 1a Dose Escalation
In this phase, researchers will try to determine the recommended dose level of BG-75098 by itself and in combination with other medicines.
- Part A: Sequential cohorts will receive increasing dose levels of BG-75098 by itself, given orally.
- Part B: Sequential cohorts will receive increasing dose levels of oral BG-75098 in combination with oral BGB-43395 and fulvestrant given as an injection into the muscle.
Phase 1b Dose Expansion
This phase will further study how safe and effective BG-75098 is at the recommended dose level identified in Phase 1a.
- Cohort 1: Participants will receive oral BG-75098 in combination with oral BGB-43395 and fulvestrant injection.
- Cohort 2: Participants will receive oral BG-75098 by itself.
Who can take part?
All cancers must be confirmed advanced, metastatic or unable to be removed with surgery (unresectable). See below for more information about specific cancers and prior treatment eligibility.
Dose Escalation Part A: Solid cancers that have a potential CDK2 dependency, have received prior treatment with standard of care systemic therapies for their advanced disease, or for whom no standard therapy is available.
Dose Escalation Part B: Solid cancers who have received 1 or more prior lines of systemic therapy in the metastatic setting.
Dose Expansion Cohort 1: Solid cancers that have progressed on prior treatment with CDK4/6 inhibitors.
Dose Expansion Cohort 2: Solid cancers that have received 1 or more line of platinum-containing chemotherapy and 4 or less prior therapeutic regimens in the advanced/metastatic setting. People with primary platinum refractory disease are not eligible.