Phase 12 Study of GI-108 as a Single Treatment for Advanced or Metastatic Solid Tumors Evaluating Safety, Tolerability, and Anti-Tumor Activity

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes pharmacokinetics, and the therapeutic effects of GI-108, an anti-CD73-IgG4 Fc-IL-2v bispecific fusion protein, in adults with advanced or metastatic solid tumors. This open-label, multicenter phase 12 study includes patients with various advanced cancers such as non-small cell lung cancer, head and neck cancer, pancreatic cancer, and renal cell carcinoma. The study aims to identify the best dose and gather early evidence of anti-tumor activity without a control group. The study has two main parts a dose escalation phase and a dose expansion phase. In dose escalation, up to 36 patients receive increasing doses of GI-108 given by intravenous infusion every three weeks to find the maximum tolerated dose or recommended dose for phase 2. Dose expansion involves giving the recommended dose to more patients to confirm safety and anti-tumor effects. Treatment may continue for up to approximately 2 years. No placebo or control arm is included. Participants will undergo safety and efficacy assessments including monitoring for dose-limiting toxicities, immune-related side effects, and tumor response using RECIST version 1.1 criteria. Blood samples will be taken to study drug levels and how GI-108 behaves in the body. Researchers will follow patients for up to about 24 months to evaluate tumor control, response duration, progression-free survival, and overall survival. The study will also track pharmacokinetic measures such as peak concentration and clearance of GI-108.

A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors