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AMG 172

Phase 1

Renal Cell Adenocarcinoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Mar 25, 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 Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01497821AMG 172 First in Human Study in Patients With Kidney CancerPHASE1 COMPLETED 37 — — Jan 1, 2012Jan 1, 2015Mar 25, 20164 United States, France +1
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Study Endpoints
Primary Endpoints
Clinically significant or ≥ Grade 3 CTCAE changes in safety laboratory tests, physical examinations, ECGs, or vital signs
28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available)
PK parameters including but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC) and half life (t1/2)
12 time points up to 8 weeks
Objective response rate for subjects treated at MTD based on RECIST 1.1
3 years
The MTD for at least one of two dosing schedules: every two weeks or every three weeks
3 years
Secondary Endpoints
Development of human anti-human antibody against AMG 172
1 year
Objective response rate for subjects not treated at MTD based on RECIST 1.1
3 years
Clinical benefit as measured by duration of response per RECIST 1.1
3 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose explorationEXPERIMENTALPre-specified nominal doses are proposed in the dose exploration at two dosing frequencies: every two weeks and every three weeks. Intermediate doses may also be used if required based on the Continuous Reassessment Method (CRM) design.
Dose expansionEXPERIMENTALDose and dosing frequency selected from Part 1 dose exploration.
Interventions
NameTypeDescription
AMG 172DRUGAMG 172 is an antibody drug conjugate
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Subjects must have a pathologically documented, definitively diagnosed, clear cell RCC that is relapsed/refractory following at least two lines of systemic therapy (one of which must be a tyrosine kinase), or the subject refuses standard therapy * Measurable disease per RECIST...

Countries:United StatesFranceGermany
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