NCT02829372

Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers

A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ichnos Sciences SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of GBR 1302 monotherapy in subjects with HER2 positive cancers

Conditions

• HER2 Expressing Solid Tumours

Interventions

Type	Name	Description
DRUG	CD3/HER2 bispecific monoclonal antibody	Increasing doses, IV on day 1 and 15 of each 28 day cycle

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2016-07-12
• Last updated: 2020-10-09

Locations

8 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study