Phase 2 Study of IBI363 Given by IV Infusion Every 2 or 3 Weeks in Adults with Advanced Solid Cancers

What this Trial Is About

Researchers are evaluating IBI363, a study drug, in adults with advanced solid cancers that have not responded to previous treatments. This Phase 2, open-label, multicenter trial aims to assess the drugs effectiveness, safety, and tolerability in people with melanoma, non-small cell lung cancer, colorectal cancer, and renal cell cancer. Participants will receive IBI363 as an intravenous infusion every two or three weeks. They will continue treatment until their disease worsens, they experience intolerable side effects, they choose to stop, the treatment duration reaches 24 months, or other reasons require stopping. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatment. During the study, participants will undergo regular assessments including monitoring of tumor response for up to two years and safety evaluations for adverse events up to 90 days after the last dose. Dose-limiting toxicities will be observed during specific time frames depending on the dosage schedule. Participants overall health and disease status will be closely followed throughout the trial period, which starts in April 2024 and ends in December 2026.

A Study of IBI363 in Subjects with Advanced Solid Malignancies