Maoming

Researchers are evaluating HLX10 monotherapy in a phase II clinical trial for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. These patients have experienced disease progression or intolerable side effects after standard cancer treatments. The study aims to assess the clinical effectiveness and safety of HLX10, a recombinant humanized anti-PD-1 monoclonal antibody, in this patient group. Participants will receive HLX10 as an intravenous infusion at a dose of 3 mg/kg every two weeks. Treatment will continue until the patient no longer benefits, experiences intolerable toxicity, withdraws consent, or completes up to 2 years of treatment (52 dosing periods). The study includes three periods: a 28-day screening phase, the treatment phase, and a follow-up phase that involves safety and survival monitoring. During the study, participants will undergo assessments including tumor measurements and laboratory tests to track treatment response and safety. Researchers will evaluate the overall response rate for up to 2 years. Regular monitoring will include imaging, blood tests, and collection of tumor tissue samples. Safety follow-up and survival status will be tracked after treatment ends to understand long-term outcomes and tolerability.