NCT02627274

A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

An Open-Label, Multicenter, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

Conditions

• Solid Tumor
• Breast Cancer
• Cancer of Head and Neck

Interventions

Type	Name	Description
DRUG	RO6874281	RO6874281 will be administered as per the schedule specified under arm description.
DRUG	Trastuzumab	Trastuzumab will be administered as per the schedule specified under arm description.
DRUG	Cetuximab	Cetuximab will be administered as per the schedule specified under arm description.

Timeline

• Start date: 2015-12-07
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2015-12-10
• Last updated: 2022-11-22

Locations

26 sites across 9 countries: United States, Belgium, Canada, Denmark, France, Italy, Netherlands, Spain, United Kingdom