A Phase I, Open-Label, Dose-Escalation Study Evaluating RO7566802 Alone and With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes, immune response, and early anti-tumor effects of a drug called RO7566802 alone and combined with atezolizumab in adults with locally advanced, recurrent, or metastatic solid tumors that cannot be cured. This first-in-human Phase I study includes two parts: dose escalation to find safe doses and expansion to further study selected doses. Participants will receive RO7566802 by intravenous infusion on the first day of each 21-day cycle. In the dose escalation phase, doses increase over successive groups, followed by combination treatment with a fixed dose of atezolizumab, also given by infusion on day 1 of each cycle, continuing until the cancer progresses or side effects become unacceptable. In the dose expansion phase, participants with certain solid tumors receive the recommended RO7566802 dose combined with atezolizumab on the same schedule. Throughout the study, participants will be closely monitored for side effects and drug levels in their blood up to about four years. Researchers will assess response to treatment using tumor measurements and track immune reactions to the drug. Safety assessments include checking for dose-limiting toxicities within the first 42 days and adverse events during the study. The overall goal is to understand how the drugs behave in the body and their preliminary activity against tumors, with ongoing follow-up for extended safety and effectiveness.

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors