A Phase 1/2 Study of MEDI4276 in Adults Subjects with Select HER2-expressing Advanced Solid Tumors. - MEDI4276
Study identifier:D5760C00001
ClinicalTrials.gov identifier:NCT02576548
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1/2 Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogencity, and Antitumor Activity of MEDI4276 in Subjects with Select HER2-expressing Advanced Solid Tumors
Medical condition
HER2 expressing Breast or Gastric/Stomach Cancers
Phase
Phase 1
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
47
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 23 Sept 2015
Primary Completion Date: 23 May 2018
Study Completion Date: 23 May 2018
Study design
Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2019 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI4276 0.05 mg/kg Participants received IV dose of 0.05 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
| Experimental: MEDI4276 0.1 mg/kg Participants received IV dose of 0.1 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
| Experimental: MEDI4276 0.2 mg/kg Participants received IV dose of 0.2 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
| Experimental: MEDI4276 0.3 mg/kg Participants received IV dose of 0.3 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
| Experimental: MEDI4276 0.4 mg/kg Participants received IV dose of 0.4 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
| Experimental: MEDI4276 0.5 mg/kg Participants received IV dose of 0.5 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
| Experimental: MEDI4276 0.6 mg/kg Participants received IV dose of 0.6 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
| Experimental: MEDI4276 0.75 mg/kg Participants received IV dose of 0.75 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
| Experimental: MEDI4276 0.9 mg/kg Participants received IV dose of 0.9 mg/kg MEDI4276 every three weeks (Q3W) for 2 years. | Biological/Vaccine: MEDI4276 MEDI4276 is an investigational product |
Contacts
Investigators
Principal Investigator
MedImmune LLC
Sponsor
