A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Phase 1
258
about 4.4 years
18+
6 sites in CA, FL, MO +3
What this study is about
This trial is testing the safety of different doses of a new drug called BG-68501 in people with advanced cancers. The goal is to determine how safe and effective this treatment is, as well as how it works in the body.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take BG-68501
- 2.Take BGB-43395
- 3.Take Fulvestrant
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
fulvestrant
injection
Primary: Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501, Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Part 2: Objective Response Rate (ORR)
Secondary: Part 1: Area under the concentration-time curve (AUC) for BG-68501 and BGB-43395, Part 1: Half-life (t1/2) for BG-68501 and BGB-43395, Part 1: Maximum observed plasma concentration (Cmax) for BG-68501 and BGB-43395, Part 1: ORR, Part 2: Number of participants with AEs and SAEs, Parts 1 and 2: Disease Control Rate (DCR), Parts 1 and 2: Duration of Response (DOR)
Oncology