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ACE-041

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

ACE-041 · 1 trial · 2 indications

Phase 1 1
NCT00996957Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple MyelomaAdvanced Solid Tumors
COMPLETED37 Analytics
PHASE1COMPLETED
Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma
Advanced Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about ACE-041

What is ACE-041 used for?

ACE-041 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It was evaluated in a Phase 1 clinical trial that also included patients with relapsed or refractory multiple myeloma. The drug is not approved and remains in clinical development.

Who makes ACE-041?

ACE-041 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company sponsored the Phase 1 clinical trial of this investigational monoclonal antibody for advanced solid tumors.

What phase is ACE-041 in?

ACE-041 is in Phase 1 clinical development. A single Phase 1 trial has been completed, and there are no active trials currently listed. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is ACE-041 in?

ACE-041 has been studied in one completed Phase 1 clinical trial, identified as NCT00996957. The trial enrolled 37 participants with advanced solid tumors or relapsed or refractory multiple myeloma and was conducted in the United States.

Is ACE-041 the same as any other drug?

ACE-041 is the primary name used for this investigational monoclonal antibody in clinical development. No alternative names have been reported for this drug in the available clinical trial information.