Phase 1 Study Evaluating XB628 Alone and with Zanzalintinib in Adults with Advanced or Metastatic Solid Tumors to Determine Safe Dosages and Preliminary Effects

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of the drug XB628 alone and in combination with zanzalintinib in adults with recurrent advanced or metastatic solid tumors. This phase 1 clinical trial includes a Dose-Escalation stage to find the maximum tolerated dose and recommended dose for expansion, followed by a Dose Expansion stage to assess the antitumor activity of these treatments. Participants receive escalating doses of XB628 through intravenous infusion, either alone or combined with oral zanzalintinib tablets. The Dose-Escalation stage aims to determine safe dosing levels, while the Dose Expansion stage evaluates initial treatment effects. Both stages involve careful monitoring of participants responses to these study drugs. During the study, participants undergo assessments to track dose limiting toxicities, treatment emergent adverse events, and objective tumor responses over periods up to 27 months. Researchers also measure drug concentration levels and immune responses. The study includes regular visits for treatment administration and safety evaluations, with follow-up to monitor treatment duration and progression-free survival.

A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors