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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

October 31, 2026

Conditions
Advanced Solid Tumor
Interventions
DRUG

Phase Ia dose-escalation part of FB849 Monotherapy

At a given level dose once daily

DRUG

Phase Ib dose-expansion of FB849 monotherapy

At recommended dose for expansion cohort once daily

DRUG

Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab

At recommended dose for expansion cohort once daily in combination with pembrolizumab

DRUG

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

DRUG

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

DRUG

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

Trial Locations (5)

22031

RECRUITING

Next Oncology Virginia, Fairfax

40118

RECRUITING

Mary Crowley Cancer Research Center, Dallas

44195

RECRUITING

Cleveland Clinic, Cleveland

78229

RECRUITING

NEXT Oncology San Antonio, San Antonio

99208

RECRUITING

Summit Cancer Centers - Spokane Valley, Spokane

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

1ST Biotherapeutics, Inc.

INDUSTRY