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BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Sponsor: BioInvent International AB
Summary
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 with BI-1808 as a single agent, BI-1808 in combination with pembrolizumab and BI-1808 in combination with pembrolizumab and paclitaxel 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),
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2021-01-25
Completion Date
2028-12-31
Last Updated
2026-09-18
Healthy Volunteers
No
Interventions
BI-1808
BI-1808 administered as a flat-dose IV infusion once every 3 weeks
Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection
Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.
Paclitaxel 80 mg/m2 weekly
Paclitaxel administered as a flat-dose IV infusion weekly.
Locations (25)
City of Hope National Medical Center
Duarte, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rigshospitalet
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
PRA Health Sciences - Hungary
Budapest, Hungary
Magyar Honvédség-Egészségügyi Központ
Budapest, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hungary
Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser
Omsk, Russia
National Medical Research Center VA Almazov
Saint Petersburg, Russia
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia
Institut Catala d'oncologia. Hospital Duran I Reynals
Barcelona, Spain
Hospital Universitario Puerta de Hierro-Majadahonda, Madrid,
Madrid, Spain
START Madrid - Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Skanes University Hospital
Lund, Sweden
Karolinska University Hospital, Solna
Stockholm, Sweden
University Hospital Birmingham
Birmingham, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
London, United Kingdom
Sarah Cannon Research Institute UK
London, United Kingdom
The Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Southampton General Hospital
Southampton, United Kingdom