RecruitingPhase 1Phase 2NCT04752826

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

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


Sponsor

BioInvent International AB

Enrollment

176 participants

Start Date

Jan 25, 2021

Study Type

INTERVENTIONAL

Conditions

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 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),


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BI-1808, both on its own and in combination with pembrolizumab (Keytruda), for people with advanced cancers — particularly a rare skin lymphoma called cutaneous T-cell lymphoma (CTCL). **You may be eligible if...** - You are 18 years or older - You have been confirmed to have an advanced cancer - You have already tried standard treatments that either didn't work or were not tolerated - For CTCL specifically, you meet phase-specific criteria for that cancer type **You may NOT be eligible if...** - You have not tried prior standard therapies - You have serious health conditions that prevent you from safely participating - Your cancer does not match the types being studied Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBI-1808

BI-1808 administered as a flat-dose IV infusion once every 3 weeks

DRUGPembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection

Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.


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 General Universitario Gregorio Marañon

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04752826


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