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Phase I/II Study of FB849 for Advanced Solid Tumors

This study is testing a new targeted therapy called FB849, alone and in combination with pembrolizumab, for people with advanced solid tumors when standard treatments are no longer an option. The main goals are to understand how safe FB849 is, how well your body handles it, and to find the best dose. Researchers will also look for early signs of how well it works against cancer. You may be able to join if you are 18 or older, have advanced solid tumors with at least one measurable lesion, and a good general health status (ECOG performance status 0 or 1). The study is currently unclear about its recruitment status and plans to enroll up to 151 participants.

Study design
This is an open-label, interventional Phase I/II study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll up to 151 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be assessed at the end of Cycle 1 (each cycle is 21 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05761223

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
1ST Biotherapeutics, Inc.
~151 participants
Updated 2025-08-17 on ClinicalTrials.gov
What's tested:Phase Ia dose-escalation part of FB849 MonotherapyPhase Ib dose-expansion of FB849 monotherapyPhase IIb dose-escalation part of FB849 in Combination with PembrolizumabPhase 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)Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with advanced solid tumors
Measured over DLT Assessment at the end of Cycle 1(each cycle is 21 days.)

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT05761223

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cleveland Clinic

    Cleveland, Ohiono site contact published

    Recruiting

  • Mary Crowley Cancer Research Center

    Dallas, Texasno site contact published

    Recruiting

  • NEXT Oncology San Antonio

    San Antonio, Texasno site contact published

    Recruiting

  • Next Oncology Virginia

    Fairfax, Virginiano site contact published

    Recruiting

  • Summit Cancer Centers - Spokane Valley

    Spokane, Washingtonno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • 1STBIO Chief Development Officer · STUDY_DIRECTOR · 1ST Biotherapeutics

Who to contact

1STBIO Information center
[email protected]
+82-31-895-4677
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with advanced solid tumorsDLT Assessment at the end of Cycle 1(each cycle is 21 days.)

    The MTD is defined to be the highest safe dose with an estimated DLT rate less than 30.