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EMD 640744

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |Merck KGaA|Last Updated: Feb 20, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

EMD 640744 · 1 trial · 1 indication

Phase 1 1
NCT01012102EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED104 Analytics
PHASE1COMPLETED
EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy
1-4 weeks

Secondary Endpoints

To assess the safety and tolerability of different doses of EMD 640744 in Montanide® ISA 51 VG in terms of laboratory parameters and adverse event profile.
3 months
To assess the clinical efficacy in terms of the overall response, progression-free survival time, and survival time.
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALEMD 640744 30μg and Montanide® ISA 51 VG
Group 2EXPERIMENTALEMD 640744 100μg and Montanide® ISA 51 VG
Group 3EXPERIMENTALEMD 640744 300μg and Montanide® ISA 51 VG

Interventions

NameTypeDescription
EMD 640744BIOLOGICALEMD 640744 30μg, weekly in initiation phase and monthly in maintenance phase (in combination with Montanide® ISA 51 VG)
Montanide ISA 51 VGOTHERAdjuvant. Montanide® ISA 51 VG, weekly in initiation phase and monthly in maintenance phase (in combination with EMD 640744 30ug)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male and female subjects ≥18 years of age * Signed written informed consent * Histologically or cytologically documented metastatic or locally advanced survivin-expressing solid tumor for which no established therapy exists * Disease must be measurable by RECIST criteria or ev...

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

Frequently asked questions about EMD 640744

What is EMD 640744 used for?

EMD 640744 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It is administered in combination with Montanide ISA 51 VG, an adjuvant, to patients with advanced solid tumors. The drug is currently in Phase 1 clinical development.

Who makes EMD 640744?

EMD 640744 is being developed by Merck KGaA, a German pharmaceutical company. Merck KGaA is publicly traded under the ticker symbol MKGAF. The company is conducting clinical trials to evaluate the safety and efficacy of EMD 640744 in patients with advanced solid tumors.

What phase is EMD 640744 in?

EMD 640744 is in Phase 1 clinical development. The drug is being studied in a Phase 1 trial for advanced solid tumors. This trial has been completed, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities.

What clinical trials is EMD 640744 in?

EMD 640744 has been studied in one clinical trial, identified as NCT01012102. This Phase 1 trial, titled 'EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors,' enrolled 104 participants aged 18 years and older. The trial has been completed.

Is EMD 640744 FDA approved?

EMD 640744 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced solid tumors. The completed Phase 1 trial evaluated the drug in combination with Montanide ISA 51 VG, but regulatory approval has not been granted.