NCT04303858

A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

An Open-Label, Multicenter, Randomized, Dose-Escalation and Extension, Phase IA/IB Study to Evaluate Safety and Anti-Tumor Activity of RO7284755, A PD-1 Targeted IL-2 Variant (IL-2V) Immunocytokine, Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an entry-into-human study and will assess the effects of eciskafusp alfa (RO7284755) as a single agent and in combination with atezolizumab in adult participants with solid tumors considered responsive to checkpoint inhibition blockade. The maximum duration in the study for each participant will be up to 28 months.

Detailed description

The study consists of three parts: dose-escalation of eciskafusp alfa as a single agent (Part 1), dose-escalation of eciskafusp alfa in combination with atezolizumab (Part 2), and extension of eciskafusp alfa as a single agent and/or in combination with atezolizumab (Part 3).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Eciskafusp Alfa	Participants will be administered eciskafusp alfa in different schedules.
DRUG	Atezolizumab	Participants will be administered 1200 mg of atezolizumab once every 3 weeks.

Timeline

• Start date: 2020-05-04
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2020-03-11
• Last updated: 2026-04-01

Locations

12 sites across 5 countries: Belgium, Denmark, Netherlands, Poland, Spain