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EMD 521873

Phase 1

Lung Cancer | Monoclonal antibody | Oncology |Merck KGaA|Trials Updated: Jul 31, 2014

EMD 521873 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Apr 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment81

FDA Designations

No designations recorded

EMD 521873 clinical trials

EMD 521873 · 2 trials · 3 indications

Phase 1 2
NCT00879866EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)Lung Cancer
COMPLETED15 Analytics
NCT01032681EMD 521873 in Advanced Solid Tumors, MTD FindingNon-Hodgkin Lymphoma
COMPLETED66 Analytics
PHASE1COMPLETED
EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)
Lung CancerUnlock trial analytics
PHASE1COMPLETED
EMD 521873 in Advanced Solid Tumors, MTD Finding
Non-Hodgkin LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety and tolerability of EMD 521873 given in combination with local irradiation of pulmonary primary tumor/metastases and to determine whether the maximum tolerated dose (MTD) is reached with EMD 521873 doses of up to 0.45 mg/kg.
Incidence of DLTs occurring during the first cycle (21 days) of administration of any dose of EMD 521873 following radiotherapy
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

Evaluate the pharmacokinetics (PK) of EMD 521873 in combination with local tumor irradiation
First 4 cycles of treatment
Evaluate the immunogenicity of EMD 521873 in combination with local tumor irradiation by measuring the induction of anti-EMD 521873 antibodies
First 4 cycles of treatment in each cycle, then every 4 cycles
Collect evidence of best overall response, changes in tumor marker levels and circulating tumor cell numbers after treatment with EMD 521873 in combination with local tumor irradiation
First 4 cycles of treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
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 521873BIOLOGICALAfter local irradiation (5 x 4 Gy) given over 5 consecutive days and 2 treatment free days cohorts of 3-6 subjects will receive EMD 521873 (as a 1h-infusion) on 3 consecutive days in 3-week cycles at dose levels of 0.15, 0.30, and 0.45 mg/kg, respectively.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Histologically or cytologically confirmed NSCLC stage IIIb with malignant pleural effusion or stage IV * Pulmonary primary tumor or at least one NSCLC metastasis in the lung measuring at least 1 cm in diameter and eligible for local radiation with 20 Gy * Disease control (part...

Countries:NetherlandsGermanySwitzerland
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Competitive Landscape -Lung Cancer 400 trials

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Frequently asked questions about EMD 521873

What is EMD 521873?

EMD 521873 is an investigational monoclonal antibody being developed by Merck KGaA for oncology. It has been studied in Phase 1 clinical trials in patients with advanced solid tumors, non-Hodgkin lymphoma, and non-small cell lung cancer. It is not an approved therapy and remains in clinical development.

What is EMD 521873 used for in lung cancer?

EMD 521873 was studied in Phase 1 for non-small cell lung cancer, where it was evaluated in combination with radiotherapy. The trial enrolled 15 patients in the Netherlands. The drug is investigational and has not been approved for lung cancer or any other indication.

What is EMD 521873 used for in non-Hodgkin lymphoma?

EMD 521873 was evaluated in a Phase 1 dose-finding study in patients with advanced solid tumors, including non-Hodgkin lymphoma. That trial enrolled 66 patients across Germany and Switzerland. The study is complete, and the drug remains investigational rather than approved for lymphoma treatment.

Who makes EMD 521873?

EMD 521873 is developed by Merck KGaA, which trades over the counter in the United States under the ticker MKGAF. The compound is an investigational monoclonal antibody in the company's oncology pipeline and has been tested in Phase 1 clinical studies.

What phase is EMD 521873 in?

EMD 521873 is in Phase 1 development. Both of its recorded clinical trials were Phase 1 studies, and both are now completed. No later-phase trials have been registered, and the drug has not been approved by the FDA or any other regulator.

What clinical trials is EMD 521873 in?

EMD 521873 has been studied in two completed Phase 1 trials. NCT01032681 tested the antibody in advanced solid tumors including non-Hodgkin lymphoma in Germany and Switzerland, enrolling 66 patients. NCT00879866 tested EMD 521873 plus radiotherapy in non-small cell lung cancer in the Netherlands, enrolling 15 patients.