Testing Lower Doses of Atezolizumab for Adults with Advanced or Metastatic Cancer Using Therapeutic Drug Monitoring

What this Trial Is About

Researchers are evaluating different doses and timing of the drug atezolizumab for adults with locally advanced or metastatic cancer. This phase I study aims to find out if lower doses of atezolizumab can maintain the drugs effectiveness while reducing side effects. The study builds on prior research showing that atezolizumab, a monoclonal antibody immune checkpoint inhibitor, has been effective in treating various tumors and is currently approved for some cancers. Participants will start treatment with FDA-approved doses of atezolizumab given intravenously every 2 to 4 weeks for the first two doses. After the second dose, blood tests will measure drug levels to adjust the timing of the third dose, which will be given at the FDA minimum dose of 840 mg. Researchers will continue to monitor drug levels before each treatment for 16 weeks and then every 3 months afterward. Treatment may last up to 2 years and can be given alone or with other FDA-approved medications. During the study, participants will undergo screening including blood tests, imaging scans, and tumor tissue sampling. Regular blood samples will be taken before each dose to monitor drug levels. Researchers will measure the feasibility of reducing drug exposure while keeping drug concentration above target levels. The study will also track how often doses are needed to maintain those levels and monitor participant safety throughout the treatment period.

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing