A Phase 1 Study of MEDI0562 in Adult Participants with Selected Advanced Solid Tumors
Study identifier:D6060C00001
ClinicalTrials.gov identifier:NCT02318394
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects with Selected Advanced Solid Tumors
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI0562
Sex
All
Actual Enrollment
56
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 02 Mar 2015
Primary Completion Date: 09 Jan 2018
Study Completion Date: 09 Jan 2018
Study design
Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2020 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI0562 Dose 1 Participants will receive an intravenous (IV) infusion of MEDI0562 Dose 1 once every 2 weeks (Q2W) or every 4 weeks (Q4W) until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. | Drug: MEDI0562 Participants will receive an IV infusion of MEDI0562 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. |
| Experimental: MEDI0562 Dose 2 Participants will receive an IV infusion of MEDI0562 Dose 2 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. | Drug: MEDI0562 Participants will receive an IV infusion of MEDI0562 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. |
| Experimental: MEDI0562 Dose 3 Participants will receive an IV infusion of MEDI0562 Dose 3 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. | Drug: MEDI0562 Participants will receive an IV infusion of MEDI0562 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. |
| Experimental: MEDI0562 Dose 4 Participants will receive an IV infusion of MEDI0562 Dose 4 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. | Drug: MEDI0562 Participants will receive an IV infusion of MEDI0562 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. |
| Experimental: MEDI0562 Dose 5 Participants will receive an IV infusion of MEDI0562 Dose 5 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. | Drug: MEDI0562 Participants will receive an IV infusion of MEDI0562 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. |
| Experimental: MEDI0562 Dose 6 Participants will receive an IV infusion of MEDI0562 Dose 6 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. | Drug: MEDI0562 Participants will receive an IV infusion of MEDI0562 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 Q2W or Q4W until unacceptable toxicity, documentation of confirmed disease progression, or other reason for treatment discontinuation develops. |
Contacts
Investigators
Principal Investigator
Medimmune LLC
MedImmune
