BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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),
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzony zaawansowany nowotwór lub przerzuty
- •Pogorszenie stanu choroby mimo standardowego leczenia
- •Co najmniej jeden widoczny guz do zmierzenia
- •Oczekiwana długość życia co najmniej 12 tygodni
- •Dobra funkcja narządów wewnętrznych
- •Zdolność do poddania się biopsji
✗ Disqualifies
- •Przerzuty do mózgu lub zapalenie opon mózgowych
- •Aktywna choroba autoimmunologiczna lub zaburzenia odporności
- •Wcześniejsze poważne powikłania ze względu na leczenie immunologiczne
- •Niekontrolowana choroba serca lub poważna infekcja
- •Duża operacja bez wystarczającego czasu na gojenie
- •Przeszczep narządu lub tkanki
- •Ciąża lub karmienie piersią
- •Alergia na składniki leku
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 18, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (25)
City of Hope National Medical Center
Duarte, United States
Memorial Sloan Kettering Cancer Center
New York, United States
University of Pennsylvania
Philadelphia, 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
Trial contact
Susanne Gertsson
Mona Welschof, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/19/2026.
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