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ACE-041

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Mar 18, 2013

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00996957Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple MyelomaPHASE1 COMPLETED 37Oct 1, 2009Oct 1, 2012Mar 18, 20134 United States
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma by monitoring adverse events, clinical laboratory tests, vital signs, physical examinations, and anti-drug antibody tests.
4 months
Secondary Endpoints
To evaluate the pharmacokinetic effect of ACE-041 through the collection of blood samples and to evaluate the preliminary anti-tumor activity of ACE-041 through tumor response evaluation, collection of blood biomarkers, and imaging techniques.
4 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACE-041EXPERIMENTALPatients assigned to 1 of 9 possible dosing groups
Interventions
NameTypeDescription
ACE-041BIOLOGICALSubcutaneous dose of ACE-041 approximately once every 3 weeks for a total of 4 doses. If disease stays the same or gets better, additional study drug may be offered.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Diagnosis of metastatic or unresectable advanced solid tumors (solid tumors must be measurable) or relapsed/refractory multiple myeloma for which the disease has progressed despite available standard therapies or for which no standard therapy exists. * Life expectancy of at le...

Countries:United States
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