A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
Public ClinicalTrials.gov record NCT05761223. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects With Advanced Solid Tumors Alone and in Combination With Pembrolizumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05761223
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 151 participants
Conditions and interventions
Conditions
Interventions
- 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
- Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 13, 2023 (Actual)
- Primary completion
- Jun 2026 (Estimated)
- Completion
- Oct 2026 (Estimated)
- Last update posted
- Aug 17, 2025
2023 – 2026
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Mary Crowley Cancer Research Center | Dallas | Texas | 40118 | Recruiting |
| NEXT Oncology San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Next Oncology Virginia | Fairfax | Virginia | 22031 | Recruiting |
| Summit Cancer Centers - Spokane Valley | Spokane | Washington | 99208 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05761223, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2025 · Synced Oct 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05761223 live on ClinicalTrials.gov.