Phase 1 Study to Find Safe Doses of GIGA-564, an Anti-CTLA-4 Antibody, in Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of GIGA-564, a monoclonal antibody, in adults with locally advanced or metastatic solid tumor cancers that are either resistant to or have relapsed after prior systemic therapy. This Phase 1 study aims to find the highest dose that participants can tolerate and recommend the best dose for further studies. The study is sponsored by GigaGen, Inc. and focuses on advanced cancer types where other treatments have limited options. Participants will receive GIGA-564 through an intravenous infusion over at least 60 minutes on the first day of every 3-week cycle. During the dose escalation phase, up to five doses ranging from 0.3 to 20 mgkg will be tested sequentially, with treatment continuing for up to 4 cycles or until disease progression or unacceptable side effects occur. Following dose escalation, selected doses may be further studied in an expansion phase with similar treatment schedules and duration. Throughout the study, participants will be closely monitored for side effects and treatment reactions up to 154 days, including severe adverse events and toxicities during the first cycle. Researchers will also measure how the cancer responds according to RECIST criteria up to 24 weeks and assess longer-term outcomes such as progression-free survival and response duration for up to 2 years. Blood levels of GIGA-564 and its pharmacokinetics will be tracked to understand how the drug behaves in the body. Overall participation may last several months with detailed safety and efficacy evaluations.

A Dose Escalation and Expansion Study of GIGA-564 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies