Study identifier:AMP-224-01
ClinicalTrials.gov identifier:NCT01352884
EudraCT identifier:N/A
CTIS identifier:N/A
-
cancer
Phase 1
No
AMP-224
All
44
Interventional
18 Years +
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Aug 2016 by MedImmune, LLC
MedImmune, LLC
GlaxoSmithKline
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Stage 1 Stage 1 will identify the recommended Stage 2 dose using a dose-escalation process. Dose-escalation will continue until either a maximum tolerated dose is established, or a therapeutic dose is reached. | Drug: AMP-224 Escalating doses of AMP-224 |
Experimental: Stage 2 Stage 2 will further explore the safety, pharmacokinetics, and preliminary clinical activity of AMP-224 in at least one tumor type based on pharmacodynamic assessments and clinical activity emerging from the Dose-Escalation Phase. Tumor tissue and blood specimens will be evaluated for pharmacodynamic markers/activity at specified timepoints throughout the study. | Drug: AMP-224 Stage 2 will further explore the safety, pharmacokinetics, and preliminary clinical activity of AMP-224 in at least one tumor type based on pharmacodynamic assessments and clinical activity emerging from the Dose-Escalation Phase. Tumor tissue and blood |