A Phase I/II Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
Phase 1/2
151
about 2.9 years
18+
5 sites in OH, TX, VA +1
What this study is about
Researchers are testing a new drug called FB849 in people with advanced solid tumors who don't have other treatment options. The trial will evaluate how safe and well-tolerated FB849 is, as well as its effects on the body (pharmacokinetics) and whether it shows any signs of working (preliminary efficacy).
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab
- 2.Take Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)
- 3.Take Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)
- +3 more
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.
pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with advanced solid tumors
Secondary: To determine the pharmacokinetic parameters such as Peak Plasma Concentration (Cmax) of FB849
Oncology