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

NCT05761223 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2025-08-17

No results posted yet for this study

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.

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

Sponsors & Collaborators

Principal Investigators

  • 1STBIO Chief Development Officer · 1ST Biotherapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2026-06-30
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761223 on ClinicalTrials.gov