This is a phase 1/2, open-label, dose-escalation and expansion study to evaluate the safety, tolerability and anti-tumor effect of GI-101 as a single agent or in combination with pembrolizumab, lenvatinib or local RT over a range of advanced and/or metastatic solid tumors.~This study will comprise four parts.~Part A: Dose-escalation and expansion cohorts of GI-101 monotherapy~Part B: Dose-escalation and expansion cohorts of GI-101 plus pembrolizumab~Part C: Dose-optimization and expansion cohorts of GI-101 plus lenvatinib~Part D: Dose-optimization and expansion cohorts of GI-101 plus local RT~GI-101 is a novel bi-specific Fc fusion protein containing the CD80 ectodomain as an N-terminal moiety and an interleukin (IL)-2 variant as a C-terminal moiety configurated via a human immunoglobulin G4 (IgG4) Fc.~Drug Information available for: Pembrolizumab (https://www.keytrudahcp.com), Lenvatinib (http://www.lenvima.com)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101 as a single agent or in combination with pembrolizumab, lenvatinib or local radiotherapy (RT) over a range of advanced and/or metastatic solid tumors.