The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.
Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
Has adequate organ and marrow function as defined in protocol.
Measurable disease as per RECIST v1.1.
ECOG performance status 0-1.
Has known active CNS metastases and/or carcinomatous meningitis.
An active second malignancy
Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.
Has active tuberculosis or has a known history of active tuberculosis
GI Innovation, Inc.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator