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AMP-224

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

AMP-224 · 1 trial · 1 indication

Phase 1 1
NCT01352884Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced CancerCancer
COMPLETED44 Analytics
PHASE1COMPLETED
Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer
Cancer
NCT0135288444
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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 to 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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Frequently asked questions about AMP-224

What is AMP-224 used for?

AMP-224 is an investigational small molecule being developed for the treatment of cancer. It is currently in clinical development for oncology indications, specifically for patients with advanced cancer. The drug is being studied to assess its safety, tolerability, and pharmacokinetics in this patient population.

Who makes AMP-224?

AMP-224 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the drug's potential as a cancer treatment.

What phase is AMP-224 in?

AMP-224 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a Phase 1 trial to assess its safety, tolerability, and pharmacokinetics in patients with advanced cancer.

What clinical trials is AMP-224 in?

AMP-224 has been studied in one clinical trial with the identifier NCT01352884. This Phase 1 study, titled 'Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer,' has been completed. The trial enrolled 44 participants in the United States.

Is AMP-224 FDA approved?

AMP-224 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial assessed its safety, tolerability, and pharmacokinetics in patients with advanced cancer, but the drug has not yet received regulatory approval.