A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849 (NCT05761223)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cleveland Clinic — Cleveland, Ohio
Age range: 18 Years
🧪 Interventions in This Study
- 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)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Cleveland Clinic — Cleveland, Ohio
- Mary Crowley Cancer Research Center — Dallas, Texas
- NEXT Oncology San Antonio — San Antonio, Texas
- Next Oncology Virginia — Fairfax, Virginia
- Summit Cancer Centers - Spokane Valley — Spokane, Washington
📞 Contact the Study Coordinator
Phone: +82-31-895-4677
Email: info@1stbio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Solid Tumor
- Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression — Iowa City, Iowa
- A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors — Glendale, California
- QTX3046 in Patients With KRAS G12D Mutations — Grand Rapids, Michigan
- A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors — Houston, Texas
- First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer — Fullerton, California
- A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors — San Antonio, Texas
Explore by condition: All Advanced Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.