A Phase 1 Study to Evaluate AMP-514
This study is currently recruiting participants.
Verified December 2013 by Amplimmune
Information provided by (Responsible Party):
First received: December 12, 2013
Last updated: December 18, 2013
Last verified: December 2013
This is a multi-center, open-label, multi-dose, first-time-in-human study with a standard 3+3 dose-escalation phase in subjects with advanced solid malignancies.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Multi-Center, Open-label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMP-514 in Subjects With Advanced Solid Malignancies|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Squamous Cell Carcinoma of the Head and Neck Liver Cancer Kidney Cancer Renal Cancer Melanoma, FamilialU.S. FDA Resources
Further study details as provided by Amplimmune:
Primary Outcome Measures:
- Number of subjects experiencing dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs) [ Time Frame: Through 90 days after last dose of AMP-514 ] [ Designated as safety issue: Yes ]Maximum tolerated dose (MTD) or optimal biological dose (OBD) will be determined by the number of subjects experiencing DLTs. Safety profile will be assessed through the number of subjects experiencing AEs, SAEs, abnormal laboratory evaluations, vital signs, and physical examinations.
Secondary Outcome Measures:
- Pharmacokinetic profile of AMP-514 [ Time Frame: Through 90 days after the last dose of AMP-514 ] [ Designated as safety issue: No ]AMP-514 concentrations in serum and PK parameters including peak concentration, area under the concentration-time curve, clearance, and half-life.
- Assess preliminary antitumor activity of AMP-514 [ Time Frame: Approximately every 3 months through 12 months following last cycle of AMP-514 ] [ Designated as safety issue: No ]Disease status evaluated via RECIST 1.1.
- Evaluate pharmacodynamic effects of AMP-514 on its target receptor, PD-1, as well as effects on immune system function [ Time Frame: Approximately every 3 months through 12 months following last cycle of AMP-514 ] [ Designated as safety issue: No ]Includes assessment of receptor occupancy, reduction in PD-1 expression levels, and increase in T cells producing effector cytokines and lytic markers
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Escalating doses of AMP-514
AMP-514 will be administered by IV infusion every 21 days
Other Name: MEDI0680
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02013804
|United States, Tennessee|
|Sarah Cannon Research Institute||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Amanda Mundy 615-329-7274 email@example.com|
|Principal Investigator: Jeffrey Infante, MD|
Sponsors and Collaborators
|Study Director:||Solomon Langermann, PhD||Amplimmune|