BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioInvent International AB
About this trial
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 criteria
Qualifiers
Is willing and able to provide written informed consent for the trial.
Is ≥18 years of age on the day of signing informed consent.
Has a histologically confirmed advanced malignancy. Subjects with CTCL [MF or SS] who satisfy the Phase 2a, Cohort 3-specific eligibility criteria may be enrolled into the Phase 1 part of the study.
Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
Disqualifiers
Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has known or suspected hypersensitivity to BI-1808 or pembrolizumab
Has cardiac or renal amyloid light-chain amyloidosis.
Trial design
Treatments tested in this trial
- BI-1808
- Pembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection
Treatment groups
176 Participants
are divided into 4 treatment groupsSponsors and collaborators
BioInvent International AB
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov