Phase Ib Study Evaluating Safety, Tolerability, and Effectiveness of HC010 with Chemotherapy in Adults with Advanced Gastrointestinal Cancer

What this Trial Is About

This research aims to assess the tolerability, safety, pharmacokinetics, and early effectiveness of the drug HC010 when combined with chemotherapy treatments in patients with advanced gastrointestinal cancers. It is a Phase Ib clinical trial designed to find the recommended dose of HC010 for future studies. The study includes patients with advanced solid tumors that cannot be treated radically with radiotherapy. Participants will receive HC010 through an intravenous drip every three weeks combined with one of several chemotherapy regimens, including Paclitaxel, Oxaliplatin plus Capecitabine, or HC006. This study is open-label and non-randomized, conducted across multiple centers, with dose range finding and multiple cohort expansions. The treatment aims to evaluate safety and dosing rather than compare to placebo. During the study, participants will undergo assessments to monitor dose-limiting toxicities within 21 days after the first dose. Researchers will also track objective response rates, disease control rates, drug concentration levels, immune responses, and adverse events for up to about two years. Patients will have regular check-ups and laboratory tests to assess how they respond to the treatment and to monitor their health throughout the trial.

A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors