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A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
Sponsor: 1ST Biotherapeutics, Inc.
Summary
This is the first-in-human, multicenter, open-label Phase I/II study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of FB849 alone and in combination with pembrolizumab in subjects with advanced solid tumors for whom no standard therapy is available.
Official title: A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects With Advanced Solid Tumors Alone and in Combination With Pembrolizumab
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
151
Start Date
2023-12-13
Completion Date
2026-10
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
Phase Ia dose-escalation part of FB849 Monotherapy
At a given level dose once daily
Phase Ib dose-expansion of FB849 monotherapy
At recommended dose for expansion cohort once daily
Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab
At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)
At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)
At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)
At recommended dose for expansion cohort once daily in combination with pembrolizumab
Locations (5)
Cleveland Clinic
Cleveland, Ohio, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
NEXT Oncology San Antonio
San Antonio, Texas, United States
Next Oncology Virginia
Fairfax, Virginia, United States
Summit Cancer Centers - Spokane Valley
Spokane, Washington, United States