NCT04158583

A Study to Evaluate the Safety and Tolerability of RO7296682 in Participants With Advanced Solid Tumors

An Open-Label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7296682, A CD25-Targeting, T-Regulatory Cell Depleting Antibody in Participants With Advanced and/or Metastatic Solid Tumor

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was planned to evaluate the safety and tolerability of RO7296682 in participants with advanced solid tumors.

Detailed description

A Phase 1, open-label, dose-escalation study designed to evaluate the safety and tolerability of RO7296682 in participants with advanced and/or metastatic solid tumors. RO7296682 was administered by IV infusion Q3W. This entry-into-human study is divided into a dose-escalation stage (Part A) and a dose expansion stage (Part B).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	RO7296682	RO7296682 will be administered by the schedules specified in the respective arms.

Timeline

• Start date: 2019-12-09
• Primary completion: 2022-07-21
• Completion: 2022-07-21
• First posted: 2019-11-12
• Last updated: 2024-03-04
• Results posted: 2024-03-04

Locations

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

Regulatory

• FDA-regulated drug study