Study of XB371 Treatment in Adults With Locally Advanced or Metastatic Solid Tumors to Evaluate Safety and Dosage

What this Trial Is About

Researchers are evaluating the safety and tolerability of a drug called XB371 in participants who have locally advanced or metastatic solid tumors. This Phase 1 study includes dose-escalation groups and expansion cohorts, with some parts randomized and others non-randomized, aiming to determine safe dose levels and observe treatment effects. The study is sponsored by Exelixis and focuses on participants with solid tumors who meet specific health and functional criteria. Participants will receive XB371 through intravenous infusion every three weeks in 21-day treatment cycles. The study has several parts a dose-escalation phase where doses increase to find the recommended levels, and two expansion phases. In Part A, participants with a selected tumor type are randomized to receive one of two recommended doses. In Part B, participants with another tumor type receive the recommended dose without randomization. Treatment continues until criteria for stopping are met. Throughout the study, participants will be monitored for dose-limiting toxicities during the first treatment cycle and treatment-emergent adverse events for approximately seven months. Researchers will measure drug levels in the blood, immune responses to the drug, and tumor response using standard criteria up to 18 months. Participants will undergo regular assessments to evaluate safety, tolerability, and treatment effects over the course of their involvement.

A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors