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AMP-224

Phase 1

Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Sep 5, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01352884Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced CancerPHASE1 COMPLETED 44 — — Mar 1, 2011Jan 1, 2014Sep 5, 20164 United States
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Study Endpoints
Primary Endpoints
Number of participants with adverse events.
From start of study drug administration until the date of first documented progression or date of death from any cause; through Day 56 of final cycle.
Number of participants with dose-limiting toxicities.
From start of study drug administration until the date of first documented progression or date of death from any cause: through Day 56 of the final cycle.
Number of participants with changes in laboratory values, vital signs, physical exam, and electrocardiogram.
From start of study drug administration until the date of first documented progression or date of death from any cause: through Day 56 of the final cycle.
Determine Maximum Tolerated Dose based on the occurrence of dose-limiting toxicities.
From start of study drug administration through Day 28 of Cycle 1.
Determine Recommended Phase 2 Dose following analysis of adverse events, pharmacokinetics and changes in laboratory evaluations.
From start of study drug administration until withdrawal; through Day 56 of final cycle.
Secondary Endpoints
Evaluate pharmacokinetics, including area under the plasma concentration versus time curve (AUC), peak plasma concentration (Cmax) and clearance of AMP-224 following single and repeat doses of AMP-224.
From Day 0 pre-dose through Day 56 of final cycle.
Evaluate Overall Response Rate (ORR), including Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression-Free Survival (PFS).
From Screening through 12 weeks following final cycle.
Characterization of the effects of AMP-224 on its receptor, PD-1, in peripheral T cells via flow cytometry and correlate with response to treatment.
From Screening until 12 weeks post-final cycle.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage 1EXPERIMENTALStage 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.
Stage 2EXPERIMENTALStage 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.
Interventions
NameTypeDescription
AMP-224DRUGEscalating doses of AMP-224
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Must be able to provide informed consent * In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma that has relapsed and is refractory to standard therapy, or for which no standard therapy exists * In Expansion Phase: Must have melanoma or ovarian can...

Countries:United States
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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