Clinical Trial

A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated August 17, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-02-27; most recent amendment 2025-08-13.
Status change: Not Yet Recruiting → Recruiting 2024-01-31
Trial Details
NCT Number NCT05761223
Lead Sponsor 1ST Biotherapeutics, Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced Solid Tumor
Enrollment 151 participants
Start Date 2023-12-13
Primary Completion 2026-06 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-08-17