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

Recruiting Phase 1 Phase 2 Interventional Study
Advanced Solid Tumor
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
151 (estimated)
Sponsor
1ST Biotherapeutics, Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Subject should understand, sign, and date the written ICF prior to screening. * Male or female aged 18 years or older. * Subjects must have at least 1 measurable target lesion according to RECIST version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or …
Contacts

1STBIO Information center

+82-31-895-4677

info@1stbio.com

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