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AMG 208

Phase 1

Cancer | Small molecule | Oncology |Amgen Inc.|Last Updated: Dec 16, 2014

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 Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00813384A Phase 1 Study of AMG 208 in Subjects With Advanced Solid TumorsPHASE1 COMPLETED 54 — — Dec 1, 2008Dec 1, 2014Dec 16, 20143 United States
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Study Endpoints
Primary Endpoints
To determine the maximum tolerated dose (MTD) of AMG 208, if possible
3.5 years
To evaluate for clinical responses associated with AMG 208 treatment in subjects (Dose Expansion) with advanced solid malignancies according to RECIST criteria
3.5 years
To characterize the pharmacokinetic (PK) exposure of AMG 208 when administered orally to subjects with advanced solid malignancies
3.5 years
To evaluate the safety and tolerability of AMG 208 in subjects with advanced solid malignancies
3.5 years
Secondary Endpoints
To evaluate for a decrease in tumor cell proliferation associated with AMG 208 treatment in subjects with advanced solid malignancies according to FLT-PET scanning
3.5 years
To assess tumor volume changes after AMG 208 treatment by computed tomography (CT) or magnetic resonance imaging (MRI)
3.5 years
To assess skin specimens for potential biomarkers
3.5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALThe dose escalation part of the study is aimed at determining the maximum tolerated dose (MTD), if feasible, and evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 208.
Dose ExpansionEXPERIMENTALThe dose expansion will consist of up to 30 subjects and the dose level of AMG 208 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
Interventions
NameTypeDescription
AMG 208DRUGAMG 208 is a small molecule inhibitor of c-Met which is a well-characterized receptor tyrosine kinase expressed on the surface of epithelial cells. C-Met receptor signaling has been shown to play a key role in the survival of cancer cells. AMG 208 inhibits both ligand-dependent and ligand-independent c-Met cellular growth regulation. Inhibition of c-Met signaling with AMG 208 provides a potential mechanism for blocking tumor growth and survival.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Men or women ≥ 18 years old * Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy * Measurable disease per RECI...

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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