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AMG 655

Phase 1

Hodgkin's Lymphoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Mar 5, 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 Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00791011Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or VorinostatPHASE1 COMPLETED 33 — — Feb 1, 2008Aug 1, 2011Mar 5, 2014 - —
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Study Endpoints
Primary Endpoints
Part 1: Safety: Subject incidence of treatment emergent adverse events, Dose Limiting Toxicities, the severity of adverse events and clinically significant changes in safety laboratory tests, physical examinations, or vital signs.
Length of Study
Part 2: Objective response rate of AMG 655 Therapy as determined by using IWG criteria at the dose selected in Part 1, in combination with Bortezomib in subjects with mantle cell lymphoma
Length of Study
Secondary Endpoints
Part 2: Overall survival (OS).
Length of study.
Part 2: Progression-Free Survival (PFS).
Length of treatment phase.
Part 2: PK parameters for AMG 655 on a 3 week dosing schedule.
Treatment and follow up phase of study.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 4EXPERIMENTALAMG 655 (intermediate dose) with Vorinostat
Cohort 1EXPERIMENTALAMG 655 (low dose) with Bortezomib
Cohort 2EXPERIMENTALAMG 655 (low dose) with vorinostat
Cohort 5EXPERIMENTALAMG 655 (high dose) with Bortezomib
Cohort 6EXPERIMENTALAMG 655 (high dose) with Vorinostat
Cohort 7EXPERIMENTALPart 2 - Mantle Cell Lymphoma subjects only: AMG 655 at dose TBD with Bortezomib
Cohort 3EXPERIMENTALAMG 655 (intermediate dose) with Bortezomib
Interventions
NameTypeDescription
AMG 655DRUGAMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
VorinostatOTHERVorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).
BortezomibOTHERA dipeptide boronic acid analogue with antineoplastic activity.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Part 1: Subjects must have a pathologically confirmed diagnosis of lymphoma that is relapsed or refractory to standard treatment or for which no curative therapy is available. Lymphoma subtypes that are eligible for enrollment include low grade lymphoma, mantle cell lymphoma, ...

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