GI-101 As a Single Agent or in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Advanced Solid Tumors

Eligibility Criteria

• * 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.
• * Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy.
• * HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol.
• * 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
• * Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.
• * History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.
• * Has an active autoimmune disease that has required systemic treatment in past 2 years.
• * Previous immunotherapies related to mode of action of GI-101.
• * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.
• * Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
• * Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy (except Part D).
• * Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
• * Known hypersensitivity to any of the components of the drug products and/or excipients of GI-101, pembrolizumab or lenvatinib.