BioInvent International AB
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),
This is a Phase 1/2a, dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study of BI-1808, as a single agent, in combination with pembrolizumab, and in BI-1808 in combination with pembrolizumab and paclitaxel 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 , B and C. 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…
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 tum…
BI-1808 administered as a flat-dose IV infusion once every 3 weeks
Pembrolizumab administered as a flat-dose IV infusion once every 3 weeks.
Paclitaxel administered as a flat-dose IV infusion weekly.