Last updated on February 2018

Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors


Brief description of study

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarcinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for review and biomarkers.

Clinical Study Identifier: NCT03102320

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Mayo Clinic Hospital

Phoenix, AZ United States
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University of Southern California

Los Angeles, CA United States
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Stanford Health Care

Stanford, CA United States
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Yale Cancer Center

New Haven, CT United States
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Georgetown University Medical Center

Washington, D.C., United States
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Mayo Clinic - Jacksonville

Jacksonville, FL United States
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IU Health University Hospital

Indianapolis, IN United States
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National Cancer Institute

Bethesda, MD United States
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Barbara Ann Karmanos Cancer Institute

Farmington Hills, MI United States
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Mayo Clinic - Rochester

Rochester, MN United States
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Texas Oncology, PA

Dallas, TX United States
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Kinghorn Cancer Centre

Darlinghurst, Australia
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Epworth HealthCare

Richmond, Australia
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UZ Antwerpen

Edegem, Belgium
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Institut Paoli Calmettes

Marseille Cedex 9, France
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C.H.U. Timone

Marseille, France
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Marienhospital

Stuttgart, Germany
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Asan Medical Center

Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Institut Catal d'Oncologia Hospitalet

L'Hospitalet de Llobregat, Spain
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Leicester Royal Infirmary

Leicester, United Kingdom
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Belfast City Hospital

Belfast, United Kingdom
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Guy's Hospital

London, United Kingdom
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Christie Hospital

Manchester, United Kingdom
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Nottingham City Hospital

Nottingham, United Kingdom
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Southampton General Hospital

Southampton, United Kingdom
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Recruitment Status: Open


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