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

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

Who can join

Ages 18 and older · All sexes

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 1
* Life expectancy ≥ 3 months in the opinion of the investigator.
* Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study treatment

Exclusion Criteria:

* Known allergy or hypersensitivity to any component of the study treatment.
* Has a known additional malignancy that is progressing or has required active treatment.
* Has abnormal or inadequately controlled endocrine function.
* Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.
* Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy, or other investigational drugs received ≤ 4 weeks; endocrine therapy ≤ 2 weeks or ≤ 5-half-lives (whichever is shorter) prior to initiation of study treatment.

About the study

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.

What is being tested

• Phase Ia dose-escalation part of FB849 Monotherapy (drug)
• Phase Ib dose-expansion of FB849 monotherapy (drug)
• Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab (drug)
• Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer) (drug)
• Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer) (drug)
• Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer) (drug)

Sponsor: 1ST Biotherapeutics, Inc. · Participants: 151 · Started: Dec 13, 2023

Contact the study team

• 1STBIO Information center · Phone: +82-31-895-4677

Official record on ClinicalTrials.gov — NCT05761223

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.