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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
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.
Details
| Lead sponsor | 1ST Biotherapeutics, Inc. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 151 |
| Start date | 2023-12-13 |
| Completion | 2026-10 |
Conditions
- Advanced Solid Tumor
Interventions
- Phase Ia dose-escalation part of FB849 Monotherapy
- Phase Ib dose-expansion of FB849 monotherapy
- Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab
- Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)
- Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)
- Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)
Primary outcomes
- 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 — DLT Assessment at the end of Cycle 1(each cycle is 21 days.)
The MTD is defined to be the highest safe dose with an estimated DLT rate less than 30.
Countries
United States