The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-108, as a single agent, in patients with advanced or metastatic solid tumors
Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) 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. 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.
Sequential
GI-108
DrugDose level will be escalated from 0.1mg/kg to 1.5 mg/kg and Recommended phase 2 dose (or RP2D) of GI-108 will be administered via IV infusion Q3W upto 2 years (approximately 35 cycles)
Incidence of Dose-Limiting Toxicities (DLTs) (Dose escalation phase)
Number and proportion of subjects experiencing DLTs during dose escalation, used to determine MTD and/or RP2D.
Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose escalation phase)
Number and proportion of subjects with immune-related AEs, graded per CTCAE v5.0.
Objective Response Rate (ORR) according to RECIST version 1.1 (Dose expansion phase)
Based on Investigator review of radiographic imaging
Objective Response Rate (ORR) according to RECIST version 1.1 (Dose escalation phase)
Based on Investigator review of radiographic imaging
Incidence and Severity of Immune-Related Adverse Events (irAEs) (Dose expansion phase)
Number and proportion of subjects with immune-related AEs, graded per CTCAE v5.0.
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have achieved CR, PR and stable disease (SD), per RECIST v1.1 guideline as determined by the investigators.
Duration of objective response (DoR)
DCR is defined as the time from the first occurrence of a documented objective response to the time of the first document disease progression or death from any cause, whichever occurs first, per RECIST v1.1 as determined by the investigator.
Immunophenotyping of peripheral blood mononuclear cells
Peripheral immune cell subpopulation (e.g., CD4+ T cells, CD8+ T cells, regulatory T cells) will be assessed.
Incidence of anti-GI-102 antibody (ADA) and neutralizing antibody (Nab)
Serum will be assessed for the presence of ADA and Nab based on the appropriate assay.
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