Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers
NCT02829372 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-10-09
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
- DRUG
-
CD3/HER2 bispecific monoclonal antibody
Increasing doses, IV on day 1 and 15 of each 28 day cycle
Sponsors & Collaborators
-
Glenmark Pharmaceuticals S.A.
collaborator INDUSTRY -
Ichnos Sciences SA
lead INDUSTRY
Principal Investigators
-
Mikhail Khazan, MD · Ichnos Sciences SA
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2019-05-31
- Completion
- 2019-05-31
- FDA Drug
- Yes
Countries
- United States
- Germany
Study Locations
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