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RECRUITING
NCT05761223
PHASE1/PHASE2

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

Sponsor: 1ST Biotherapeutics, Inc.

View on ClinicalTrials.gov

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

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

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