Phase 12 Study to Assess the Safety and Effectiveness of IBB0979 in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating IBB0979 in a Phase 12 open-label study involving patients with locally advanced or metastatic solid tumors who have previously received treatment. The study aims to understand the safety, tolerability, pharmacokinetics, immune response, and early signs of antitumor activity of IBB0979. This investigational drug is being studied in patients whose tumors have progressed after standard therapies or for whom no standard treatment exists. The study includes three phases Dose Escalation, Dose Expansion, and Clinical Exploration. In the Dose Escalation Phase, patients receive increasing doses of IBB0979, administered by subcutaneous injection, following a 33 design to determine safe dose levels. The Dose Expansion Phase enrolls patients to receive the established maximum tolerated dose in 21-day treatment cycles until withdrawal or discontinuation. After these phases, investigators and sponsors will discuss further exploration based on the collected safety and efficacy data. Participants will undergo regular assessments including monitoring for adverse events, dose-limiting toxicities, and response to treatment using tumor measurements. Pharmacokinetic samples will be collected at multiple time points during each 21-day cycle, and immunogenicity will be evaluated. The main outcomes include safety events and objective tumor response rates over up to two years. The total study duration varies by participant, with follow-up extending to monitor long-term effects and survival.

A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors