Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating an investigational drug called SYS6043 in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. This open-label, multicenter Phase I study aims to assess the safety, tolerability, pharmacokinetics, and early anti-tumor effects of SYS6043, which targets the B7-H3 protein. The study also explores how the drug moves through the body and whether the immune system responds to it, with a focus on determining the dose that can be safely given to patients. The study has three parts: dose escalation, pharmacokinetic expansion, and cohort expansion. Initially, doses are increased carefully to find the maximum tolerated dose or recommended Phase II dose. Next, selected doses are further studied for safety, drug behavior, and tumor response. The final part involves expanding participant groups to assess safety and effectiveness at the chosen dose. SYS6043 is given by intravenous infusion every three weeks, and dosing continues until the doctor decides to stop based on treatment response. Participants will provide consent, undergo screening tests, and attend all study visits. Researchers will monitor safety through adverse event tracking and follow participants until their disease progresses. Various assessments include tumor measurements, heart function tests, and immune response checks. Safety follow-up and long-term monitoring are included, with an average study duration of about one year for key outcomes such as adverse events, drug levels, tumor response, and protein expression related to treatment effects.

Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors