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
BioInvent International AB
Summary
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),
Description
This is a Phase 1/2a, dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study of BI-1808, as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. The study will consist of 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A and B. Phase 1 Part A consists of a dose escalation of BI-1808 as a single agent to evaluate safety and tolerability and to determine the RP2D as a single agent (sRP2D) in subjects with advanced malignancies whose disease has progressed a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Is willing and able to provide written informed consent for the trial. 2. Is ≥18 years of age on the day of signing informed consent. 3. 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. 4. Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy. 5. Has at least 1 measurable disease lesion as defined by RECIST. 6. Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-…
Interventions
- DrugBI-1808
BI-1808 administered as a flat-dose IV infusion once every 3 weeks
- DrugPembrolizumab (KEYTRUDA® ) 25 Mg/mL Solution for Injection
Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.
Locations (25)
- City of Hope National Medical CenterDuarte, California
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University of PennsylvaniaPhiladelphia, Pennsylvania
- RigshospitaletCopenhagen
- Herlev HospitalHerlev
- PRA Health Sciences - HungaryBudapest