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

Condition(s) studied

Investigational drug(s) / intervention(s)

BG-75098: Administered orally.

BGB-43395: Administered orally.

Fulvestrant: Administered by intramuscular injection.

Study 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.

Eligibility

Primary outcome measure(s)

• Phase 1a: Number of Participants with Adverse Events (AEs) — From first dose to 30 days after last dose, up to approximately 12 months
  Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria.
• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-75098 — Up to approximately 2 years
  MTD is determined based on a target for dose-limiting toxicities. MAD is defined as the maximum administered dose, and it is used when MTD is not reached.
• Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-75098 as Monotherapy and in Combination with BGB-43395 and Fulvestrant — Up to approximately 2 years
  The RDFE(s) will be determined from safety, tolerability, pharmacokinetic, pharmacodynamic biomarker(s), preliminary antitumor activity, and any other relevant data that are obtained from the dose escalation phase.
• Phase 1b: Objective Response Rate (ORR) as Assessed by the Investigator — Up to approximately 2 years
  ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.

Trial sites (22)