BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this 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),
Sponsor: BioInvent International AB
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04752826 · last updated 2026-09-18