BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20) (NCT04752826)
Phase 1/2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 as a Single Agent and in Combination With Pembrolizumab (MK-3475-D20) in Subjects With Advanced Malignancies
🩺 Plain-English Summary (8th-Grade Level)
The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy. The main questions it aims to answer are: * how safe and tolerable is BI-1808 * what is maximum tolerated or administrated dose * to determine recommended dose for further clinical trials. Participants will receive infusions of BI-1808 alone or combination with pembrolizumab every 3 weeks. For the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors and subjects with T-cell lymphoma (TCL),
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "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 (25 Sites)
- City of Hope National Medical Center — Duarte, California
- Memorial Sloan Kettering Cancer Center — New York, New York
- University of Pennsylvania — Philadelphia, Pennsylvania
- Rigshospitalet — Copenhagen,
- Herlev Hospital — Herlev,
- PRA Health Sciences - Hungary — Budapest,
- Magyar Honvédség-Egészségügyi Központ — Budapest,
- Debreceni Egyetem Klinikai Központ — Debrecen,
- Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser — Omsk,
- National Medical Research Center VA Almazov — Saint Petersburg,
- N.N. Petrov National Medical Research Center of Oncology — Saint Petersburg,
- Institut Catala d'oncologia. Hospital Duran I Reynals — Barcelona,
- Hospital General Universitario Gregorio Marañon — Madrid,
- START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid,
- Hospital Universitario 12 de Octubre — Madrid,
- Sahlgrenska University Hospital — Gothenburg,
- Skanes University Hospital — Lund,
- Karolinska University Hospital, Solna — Stockholm,
- University Hospital Birmingham — Birmingham,
- University Hospitals of Leicester NHS Trust — Leicester,
- Guy's and Saint Thomas' NHS Foundation Trust — London,
- Sarah Cannon Research Institute UK — London,
- The Royal Marsden Hospital NHS Foundation Trust — London,
- The Christie NHS Foundation Trust — Manchester,
- Southampton General Hospital — Southampton,
📞 Contact the Study Coordinator
Phone: +46462868550
Email: susanne.gertsson@bioinvent.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.
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💡 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.