Actively Recruiting
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
Led by 1ST Biotherapeutics, Inc. · Updated on 2025-08-17
151
Participants Needed
5
Research Sites
146 weeks
Total Duration
On this page
Sponsors
1
1ST Biotherapeutics, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject should understand, sign, and date the written informed consent form 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 of at least 3 months as judged by the investigator.
- Adequate organ and bone marrow function based on screening tests performed within 14 days before the first dose of study treatment.
You will not qualify if you...
- Known allergy or hypersensitivity to any component of the study treatment.
- Presence of an additional progressing malignancy requiring active treatment.
- Abnormal or inadequately controlled endocrine function.
- Inability to take oral medication or significant nausea, vomiting, malabsorption, external biliary shunt, or bowel resection preventing adequate absorption of oral medication.
- Received previous anti-cancer therapy including chemotherapy (except nitrosourea or mitomycin chemotherapy must be at least 6 weeks prior), radiotherapy, targeted therapy, investigational drugs within 4 weeks, or endocrine therapy within 2 weeks or 5 half-lives prior to study treatment start.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
2
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 40118
Actively Recruiting
3
NEXT Oncology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
4
Next Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
Summit Cancer Centers - Spokane Valley
Spokane, Washington, United States, 99208
Actively Recruiting
Research Team
1
1STBIO Information center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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