NCT06537310

A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors

An Open-label, Multicenter, Dose-escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.

Conditions

• Cancer-Neoplasms

Interventions

Type	Name	Description
DRUG	RO7567132 and Atezolizumab	RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
DRUG	RO7567132 and Atezolizumab	RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.

Timeline

• Start date: 2024-09-16
• Primary completion: 2027-05-12
• Completion: 2027-08-10
• First posted: 2024-08-05
• Last updated: 2026-03-03

Locations

11 sites across 5 countries: Australia, Belgium, Canada, Denmark, Spain

Regulatory

• FDA-regulated drug study