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EMD 521873

Phase 1

Non-Hodgkin Lymphoma | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jul 31, 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 Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01032681EMD 521873 in Advanced Solid Tumors, MTD FindingPHASE1 COMPLETED 66 — — Dec 1, 2006Jan 1, 2012Jul 31, 20145 Germany, Switzerland
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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 — 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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