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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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),
What is being tested
- BI-1808 (drug)
- Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection (drug)
- Paclitaxel 80 mg/m2 weekly (drug)
Sponsor: BioInvent International AB · Participants: 250 · Started: Jan 25, 2021
Contact the study team
- Susanne Gertsson · Phone: +46462868550
- Mona Welschof, PhD · Phone: +47 97088721
Official record on ClinicalTrials.gov — NCT04752826
Locations in the U.S.
| California | City of Hope National Medical Center, Duarte |
| New York | Memorial Sloan Kettering Cancer Center, New York |
| Pennsylvania | University of Pennsylvania, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.