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EMD 521873

Phase 1

Non-Hodgkin Lymphoma | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jul 31, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

EMD 521873 · 1 trial · 1 indication

Phase 1 1
NCT01032681EMD 521873 in Advanced Solid Tumors, MTD FindingNon-Hodgkin Lymphoma
COMPLETED66 Analytics
PHASE1COMPLETED
EMD 521873 in Advanced Solid Tumors, MTD Finding
Non-Hodgkin LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Assess the safety and tolerability of EMD 521873
First administration of any dose of EMD521873 until last administration plus 30 days.
To determine whether the MTD is reached with EMD 521873 doses of up to 1.5 mg/kg given alone or in combination with fixed, low-dose CPA in patients with metastatic or locally advanced solid tumors or B-cell non-Hodgkin lymphoma
Incidence of DLTs occurring during the first cycle of administration of any dose of EMD 521873 given alone on 3 times per cycle (group 1) or with fixed low-dose CPA plus EMD 521873 (group 2) or of EMD 521873 given alone on once per cycle (group 3).

Secondary Endpoints

Characterize the PK profile of EMD 521873 alone or in combination with fixed lowdose CPA
Cycle 1-3 of EMD 521873 treatment
Evaluate the immunogenicity of EMD 521873 alone or in combination with CPA measured by the induction of o Specific antibodies against the genetically modified IL-2 o Fc-IL2-specific antibodies o Anti-idiotype antibodies
Every EMD 521873 treatment cycle
Collect evidence of best overall response, changes in serum tumor marker levels and best clinical response after treatment with EMD 521873 alone or in combination with CPA
Every second EMD 521873 treatment cycle
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALDose escalation of EMD 521873 monotheraphy 3 doses per cycle
Group 2EXPERIMENTALLow dose CPA + Dose escalation of EMD 521873 three doses per cycle
Group 3EXPERIMENTALDose escalation of EMD 521873 monotheraphy 1 dose per cycle

Interventions

NameTypeDescription
EMD 521873BIOLOGICALDose escalation steps: Group 1: 0,075mg/kg - 0,15mg/kg - 0,225mg/kg - 0,3mg/kg - 0,45mg/kg - 0,6mg/kg - 0,9mg/kg (-1,8mg/kg - 2,1mg/kg - 2,5mg/kg - 3,0mg/kg) Disease control and decision of continuation in patient who benefit from the treatment: Every second cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Signed written informed consent 2. Male or female, aged ≥ 18 years, inpatient for treatment phase of cycle 1 and 2, outpatient treatment possible for subsequent cycles 3. Histologically or cytologically proven metastatic or locally advanced solid tumors (epithelial or mesench...

Countries:GermanySwitzerland
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Frequently asked questions about EMD 521873

What is EMD 521873 used for?

EMD 521873 is a monoclonal antibody being developed for the treatment of Non-Hodgkin Lymphoma. It is an investigational therapy currently in clinical development for this oncology indication.

Who makes EMD 521873?

EMD 521873 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK.

What phase is EMD 521873 in?

EMD 521873 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for commercial use.

What clinical trials is EMD 521873 in?

EMD 521873 has been studied in one completed Phase 1 clinical trial, identified as NCT01032681. This trial enrolled 66 participants and was conducted in Germany and Switzerland.

Is EMD 521873 being studied in a randomized or blinded trial?

The completed Phase 1 trial of EMD 521873 was not randomized and was not double-blinded. The trial was controlled, meaning participants received a control treatment for comparison.

What is the mechanism of action of EMD 521873?

EMD 521873 is a monoclonal antibody, a type of biologic therapy designed to target specific proteins involved in disease. Its exact molecular target has not been disclosed in available clinical trial information.