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EMD 521873

Phase 1

Lung Cancer | Monoclonal antibody | Oncology |Merck KGaA|Last Updated: Jun 23, 2014

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

EMD 521873 · 1 trial · 2 indications

Phase 1 1
NCT00879866EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)Lung Cancer
COMPLETED15 Analytics
PHASE1COMPLETED
EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)
Lung CancerUnlock 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

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 -

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:Netherlands
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Competitive Landscape -Lung Cancer 281 trials

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Frequently asked questions about EMD 521873

What is EMD 521873 used for?

EMD 521873 is an investigational monoclonal antibody being studied for the treatment of lung cancer, specifically non-small cell lung cancer (NSCLC). It is being evaluated in combination with radiotherapy in patients with this condition.

Who makes EMD 521873?

EMD 521873 is being developed by Merck KGaA, a pharmaceutical company traded under the ticker MKGAF. The drug is currently in clinical development for oncology indications, including lung cancer.

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. One Phase 1 trial has been completed, and the drug is not currently in active trials.

What clinical trials is EMD 521873 in?

EMD 521873 has been studied in one clinical trial, NCT00879866, titled 'EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)'. This Phase 1 trial enrolled 15 participants in the Netherlands and has been completed.

How does EMD 521873 work?

EMD 521873 is a monoclonal antibody, a type of targeted therapy designed to bind to specific proteins involved in cancer growth. Its exact molecular target has not been disclosed in available information.