Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by 1ST Biotherapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MTD is defined to be the highest safe dose with an estimated DLT rate less than 30.
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 |
What NCT05761223 shows while recruiting
NCT05761223 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (21% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05761223's enrollment target sits among peer trials
151 85th of 189 higher than 105 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
PM14 Administered Intravenously to Patients with Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
RECRUITING · Phase 1
-
Study of AVZO-021 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01409161 · 151 participants · Phase 2
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
- NCT04245397 · 151 participants · Phase 1
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
- NCT07195656 · 151 participants · NA
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
- NCT03328078 · 152 participants · Phase 1
CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI