🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllBioInvent International AB
NCT04752826 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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),

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * Able and willing to provide written informed consent. * Aged 18 years or older. * Histologically confirmed advanced or metastatic malignancy eligible for an enrolling study cohort. * Disease progression following, intolerance of, ineligibility for, or refusal of applicable standard therapy. * At least one measurable lesion according to the response criteria specified in the protocol. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Life expectancy of at least 12 weeks. * Adequate organ function. * Willing and medically suitable to provide required tumor or skin biopsies. * Meets the disease-specific and treatment-history requirements of the applicable Phase 2a cohort. * For Phase 2a Part C: Histologically confirmed platinum-resistant high-grade serous or clear-cell ovarian carcinoma, prior platinum-based treatment as specified in the protocol, and suitability for paclitaxel treatment. Exclusion Criteria: 1\. Active central nervous system metastases or carcinomatous meningitis. * Active or clinically significant autoimmune disease, immunodeficiency, or use of prohibited immunosuppressive treatment. * Prior treatment-related toxicity not recovered to the level specified in the protocol. * Prior anticancer therapy, radiotherapy, immunotherapy, investigational treatment, or live vaccine within the protocol-defined washout period. * History of clinically significant immune-mediated toxicity, including pneumonitis, associated with previous immune-checkpoint inhibitor treatment. * Uncontrolled or clinically significant cardiovascular disease, serious infection, or another condition that could compromise safety or study participation. * Major surgery without adequate recovery. * Prior allogeneic tissue or solid-organ transplantation or active graft-versus-host disease. * Pregnancy or breastfeeding, or unwillingness to comply with protocol-defined contraceptive requirements. * Known hypersensitivity to a study treatment or its components. * Another active malignancy, except for protocol-defined permitted malignancies. * Participation in another interventional clinical trial that conflicts with this study. * Unable or unlikely to comply with study procedures and requirements. * For Phase 2a Part C: Receipt of prohibited colony-stimulating factors within the protocol-defined period before treatment.
💊

What it tests

  • BI-1808
  • Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection
  • Paclitaxel 80 mg/m2 weekly
📍

Where

25 sites
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

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy