A First-in-human Trial of BGB-53038
Phase 1
514
about 2.1 years
18+
4 sites in CA, KS, MD +1
What this study is about
Researchers are testing a new drug called BGB-53038 to see if it's safe and effective in people with advanced cancers that have KRAS mutations or amplifications. The trial will also explore whether BGB-53038 works better when combined with other medications like tislelizumab or cetuximab.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take BGB-53038
- 2.Take Cetuximab
- 3.Take Tislelizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
cetuximab, tislelizumab
injection (Injection)
Primary: Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-53038, Phase 1a: Number of Participants Experiencing Adverse Events (AEs), Phase 1b: Overall Response Rate (ORR)
Secondary: Disease Control Rate (DCR), Duration of Response (DOR), Phase 1a: Single-dose and steady-state Half-life (t1/2) of BGB-53038, Phase 1a: Single-dose and steady-state area under the concentration-time curve (AUC) of BGB-53038, Phase 1a: Single-dose and steady-state maximum observed plasma concentration (Cmax) of BGB-53038, Phase 1b: Number of Participants Experiencing Adverse Events (AEs), Phase 1b: ORR, Phase 1b: Overall Survival (OS)
Oncology