A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
Phase 1
90
about 2.6 years
18+
5 sites in FL, PA, SD +2
What this study is about
This trial is testing if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6. The main questions it aims to answer are what the recommended dosing for BGB-B455 is and what medical problems participants have when taking BGB-B455. It has two parts: Phase 1a, which involves dose escalation and safety expansion, and Phase 1b, which involves dose expansion.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take BGB-B455
- 2.Take Chemotherapy
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.
Primary: Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B455, Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs), Phase 1b: Overall Response Rate (ORR)
Secondary: Phase 1a and 1b: Apparent clearance (CL) of BGB-B455, Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-B455, Phase 1a and 1b: Disease Control Rate (DCR), Phase 1a and 1b: Duration of Response (DOR), Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-B455, Phase 1a and 1b: Terminal half-life (t1/2) of BGB-B455, Phase 1a and 1b: Time to Response (TTR), Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-B455
Oncology