Phase 1 and 2 Study of XNW28012 for Safety and Effectiveness in Adults With Advanced Solid Tumors Who Have Not Responded to Standard Treatments

What this Trial Is About

Researchers are evaluating XNW28012 in adults with advanced solid tumors who have not responded to or cannot tolerate standard anti-tumor treatments. This phase 1, first-in-human study is open-label and multicenter, aiming to assess the safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity of XNW28012. The study includes two parts dose escalation and dose expansion, focusing on multiple solid tumor types such as ovarian, cervical, pancreatic, and colorectal cancers. Participants will receive XNW28012 intravenously every three weeks at increasing doses determined by a Bayesian Optimal Interval method, starting from 0.6 mgkg up to 7.5 mgkg during the dose escalation phase. Treatment continues until intolerable side effects, disease progression without benefit, or withdrawal of consent. The first treatment cycle is carefully monitored for dose-limiting toxicities to guide safe dosing. The subsequent dose expansion part involves treating patients at the recommended dose identified from the escalation phase. Throughout the study, participants will undergo regular safety assessments, including monitoring treatment-related adverse events, organ function tests, and tumor response evaluations. Imaging and clinical evaluations for tumor progression will occur at scheduled intervals up to one year. Researchers will also measure drug levels, immune response to the drug, and tumor control outcomes. Participants are followed closely to evaluate treatment effects, side effects, and overall health status during and after therapy.

Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments