Phase 12 Study of ST-067 Alone or With Obinutuzumab or Pembrolizumab in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are studying ST-067, an engineered variant of human interleukin-18, in patients with advanced solid tumors that have returned or not responded to prior treatments. This study includes a Phase 1a dose escalation to find the safest and most effective dose of ST-067 given by subcutaneous or intravenous routes, alone or with obinutuzumab pre-treatment or combined with pembrolizumab. The Phase 2 part will assess the preliminary effectiveness of ST-067 at the recommended dose in various cancers such as melanoma, renal cell carcinoma, triple-negative breast cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, and MSI-High tumors. In Phase 1a, patients receive weekly doses of ST-067 starting at 30 gkg subcutaneously or 60 gkg intravenously, with dose levels adjusted based on safety findings. Some patients get obinutuzumab intravenously as a pre-treatment before ST-067 or receive ST-067 combined with pembrolizumab every three weeks. The dose limiting toxicity period is 28 days after the first ST-067 dose. Phase 2 will treat patients weekly with ST-067 at the recommended dose determined in Phase 1, focusing on specific tumor types. Participants will be closely monitored for safety, side effects, and how their cancer responds to treatment by assessing measurable tumor lesions every 8 to 12 weeks using RECIST 1.1 criteria. Blood samples will be collected to study how the drug behaves in the body and immune responses. The study team will evaluate maximum tolerated dose, safety, tolerability, and initial effectiveness. The entire study includes ongoing safety assessments and could continue until the end of 2025.

Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067