Tests BI-1808 alone and with pembrolizumab in advanced cancers
Tests BI-1808, an antibody, alone and with pembrolizumab in advanced cancers.
Plain-language title generated from the registry record
Registry title: BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Key facts
- Where
- Copenhagen and Herlev, DenmarkSee the 2 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Have you ever been told you have ovarian, fallopian tube or peritoneal cancer?
- Have your doctors told you that your cancer is advanced (stage 3 or 4)? This means it has spread beyond the ovaries to other parts of the belly or the body, even if it was later removed by surgery.
- Has your cancer spread to the brain or the spinal cord?
Source: NCT04752826, who can take part
Where in Denmark
- RigshospitaletCopenhagen, DenmarkTaking people
- Herlev HospitalHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioInvent International AB
- Trial code
- NCT04752826EU 2023-509847-29-00
- Record updated
- 18 September 2026
- Original description
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.Read full original descriptionShow less
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
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),
Inclusion: 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: 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; Major surgery without adequate recovery; Prior allogeneic tissue or solid-organ transplantation or active graft-versus-host disease; Active or clinically significant autoimmune disease, immunodeficiency, or use of prohibited immunosuppressive treatment; Uncontrolled or clinically significant cardiovascular disease, serious infection, or another condition that could compromise safety or study participation; Known hypersensitivity to a study treatment or its components; Another active malignancy, except for protocol-defined permitted malignancies; Active central nervous system metastases or carcinomatous meningitis; Pregnancy or breastfeeding, or unwillingness to comply with protocol-defined contraceptive requirements; 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.