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

Source: https://onco.cc/trials/nct05761223/  
OnCo record `nct05761223` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Pembrolizumab in advanced solid tumours, run by 1ST Biotherapeutics, Inc., now recruiting.

## Summary

A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849 is a phase 1/2 interventional study registered as NCT05761223 by 1ST Biotherapeutics, Inc., with 151 participants planned, started 2023-12-13 and due to reach its primary completion in 2026-06. Interventions recorded: 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) and Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer).

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05761223
- Phase: 1/2
- Setting: 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
- Sponsor: 1ST Biotherapeutics, Inc.
- Enrolled: 151

## Sources

- ClinicalTrials.gov NCT05761223: https://clinicaltrials.gov/study/NCT05761223

## Connected records

- cancers: [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/)

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