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MetMAb

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: May 19, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment137

FDA Designations

No designations recorded

Clinical trial landscape

MetMAb · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00854308A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)Non-Small Cell Lung Cancer
COMPLETED137 Analytics
PHASE2COMPLETED
A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival
Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)

Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).

Progression-free Survival in Patients With Met Diagnostic-Positive Tumors
Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)

Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry. PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).

Safety and tolerability of MetMAb alone or in combination with bevacizumab will be assessed (frequency and nature of dose-limiting toxicities; nature, severity, and relatedness of adverse events; changes in vital signs and clinical laboratory parameters)
Length of study

Secondary Endpoints

Percentage of Participants With Objective Response
Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors
Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
Duration of Overall Response
Date of initial response until date of progression or death on study. (Up to 20 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MetMAb + ErlotinibEXPERIMENTALMetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
Placebo + ErlotinibPLACEBO_COMPARATORPlacebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
Stage IEXPERIMENTAL -
Stage IIEXPERIMENTAL -
Stage IIIEXPERIMENTAL -

Interventions

NameTypeDescription
Erlotinib HClDRUGErlotinib 150 mg oral dose once daily.
MetMAbDRUGMetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.
placebo (0.9 % saline)DRUGPlacebo Intravenous infusion every 3 weeks.
bevacizumabDRUGRepeating intravenous dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: Patients must meet the following criteria for study entry: * Histologically confirmed NSCLC * Availability of a tumor specimen * Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease * Measurable disease in accordance with Re...

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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about MetMAb

What is MetMAb used for in Non-Small Cell Lung Cancer?

MetMAb is an investigational drug studied for use in advanced Non-Small Cell Lung Cancer. It was evaluated in a Phase 2 clinical trial in combination with Tarceva (erlotinib) for patients with this condition. MetMAb is also being studied for solid cancers, but it is not approved and remains in clinical development.

What does MetMAb target?

MetMAb is a monovalent antagonist antibody that targets the receptor c-Met. By binding to c-Met, it is designed to block signaling through this receptor, which is involved in cancer cell growth and survival. This mechanism was evaluated in clinical trials for solid tumors and Non-Small Cell Lung Cancer.

Who makes MetMAb?

MetMAb is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the pharmaceutical company responsible for advancing this investigational drug through clinical trials for oncology indications.

What phase is MetMAb in?

MetMAb is in Phase 2 clinical development. It has completed a Phase 2 trial in Non-Small Cell Lung Cancer and a Phase 1 trial in solid cancers. MetMAb is investigational and has not been approved by regulatory authorities.

What clinical trials is MetMAb in?

MetMAb has been studied in two completed clinical trials. NCT00854308 was a Phase 2 study of MetMAb combined with Tarceva (erlotinib) in advanced Non-Small Cell Lung Cancer with 137 participants. NCT01068977 was a Phase 1 study of MetMAb alone in patients with locally advanced or metastatic solid tumors with 44 participants.

Is MetMAb the same as PRO143966?

Yes, MetMAb is also known as PRO143966. In clinical trial records, it is referred to as MetMAb (PRO143966), a monovalent antagonist antibody to the receptor c-Met. Both names refer to the same investigational drug being developed by Roche.