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A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
NCT05761223 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG 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)
Study Locations (5)
Texas
- Mary Crowley Cancer Research Center — Dallas
- NEXT Oncology San Antonio — San Antonio
Ohio
- Cleveland Clinic — Cleveland
Virginia
- Next Oncology Virginia — Fairfax
Washington
- Summit Cancer Centers - Spokane Valley — Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05761223
The ClinicalTrials.gov registry entry for NCT05761223 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is 1ST Biotherapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions — of which Phase Ia dose-escalation part of FB849 Monotherapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05761223 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Texas, Ohio, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05761223 about?
NCT05761223 is a clinical study titled "A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849". 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 ...
What is the current status of trial NCT05761223?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2023-12-13. Estimated completion is 2026-10.
What conditions does trial NCT05761223 study?
This clinical trial studies the following conditions: Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05761223?
The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05761223?
This trial is sponsored by 1ST Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05761223 being conducted?
This trial has 5 study locations across Ohio, Texas, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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