Phase IIIII Study Evaluating sEphB4-HSA Combined With Immunotherapy in Patients With EphrinB2-High Solid Tumors

What this Trial Is About

Researchers are studying patients with solid tumors that show high levels of EphrinB2 to evaluate the effects of adding the EphrinB2 inhibitor sEphB4-HSA to treatment regimens. The study aims to demonstrate whether combining sEphB4-HSA with immunotherapy improves treatment outcomes compared to standard care, focusing on safety and key cancer-related results in different patient groups. This is a modular, open-label, randomized trial involving patients with muscle-invasive bladder carcinoma MIBC and metastatic urothelial carcinoma mUC that express EphrinB2. Participants are assigned to different groups based on their cancer type and treatment eligibility. One group receives sEphB4-HSA combined with pembrolizumab, while the control group receives standard treatments such as gemcitabine-cisplatin or pembrolizumab alone for MIBC, or enfortumab vedotin plus pembrolizumab for mUC. sEphB4-HSA is given intravenously at 10 mgkg on days 1 and 8 of each cycle, with treatment continuing until disease progression or unacceptable side effects. The trial includes up to four cycles of therapy, with dose modifications and scheduling managed by the treating physician. Participants will have regular assessments to monitor safety and treatment effects, including pathological response, overall survival, and radiographic response rates over up to five years. Laboratory tests and tumor profiling are required before enrollment, and performance status will be evaluated. The study also tracks disease-free and progression-free survival and records any toxicities related to the treatments. Follow-up visits and safety monitoring occur throughout the study to ensure participants are closely observed until study completion or withdrawal.

Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors