Phase IIIII Study of PRL3-Zumab for Adults With Advanced Solid Tumors Evaluating Safety and Effectiveness of PRL3-Zumab Monotherapy

What this Trial Is About

Researchers are evaluating PRL3-zumab monotherapy in patients with advanced solid cancers in a multicenter, open-label Phase IIIII trial. This study aims to assess the safety and effectiveness of a single dose level of PRL3-zumab 6 mgkg given intravenously every two weeks, focusing on progression-free survival and time to progression based on tumor response. The trial includes patients with stage 1-3 solid tumors who have had no more than three prior treatments and a life expectancy of more than six months. PRL3-zumab is administered by intravenous infusion every two weeks until the patient experiences disease progression, intolerable side effects, or withdraws consent. One treatment cycle consists of two infusions over four weeks, with safety assessments including laboratory tests done before each infusion. Tumor response is evaluated using iRECIST criteria at baseline and after every four doses. Quality of life questionnaires are completed at screening and every four doses during treatment. The study also includes a screening period before treatment, an end-of-treatment visit within two weeks of the last dose, a safety follow-up visit 28 days after treatment ends, and monthly survival follow-up calls for six months after the study concludes. Participants will undergo regular physical exams, vital sign monitoring, laboratory tests, and questionnaires to assess quality of life throughout the study. Safety is closely monitored using standard criteria for adverse events. The primary outcomes are progression-free survival and time to progression assessed up to 12 months after the first dose. Secondary outcomes include clinical benefit rate measured every eight weeks up to 48 weeks. The total treatment duration varies by patient depending on response and tolerance, with ongoing safety follow-up and survival monitoring for six months after treatment completion.

Phase II/III Trial of PRL3-Zumab in Advanced Solid Tumor Patients