NCT03448042

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

A Phase Ia/Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Runimotamab	Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
DRUG	Trastuzumab	Trastuzumab will be administered via IV infusion
DRUG	Tocilizumab	Participants will receive IV tocilizumab if needed

Timeline

• Start date: 2018-06-06
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2018-02-27
• Last updated: 2026-02-27

Locations

27 sites across 14 countries: United States, Australia, Belgium, Canada, Denmark, France, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study