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NCT05761223 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
A Phase 1 study of Advanced Solid Tumor, sponsored by 1ST Biotherapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 151
- Enrollment target
- 5
- Study locations
NCT05761223 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by 1ST Biotherapeutics. The registered enrollment target is 151 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (21% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT05761223, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by 1ST Biotherapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 151 participants
- Enrollment target
- 5
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (21% lower). The listed sponsor is 1ST Biotherapeutics, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT05761223 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Texas, Ohio, Virginia.
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.
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).
Who is sponsoring clinical trial NCT05761223?
This trial is sponsored by 1ST Biotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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