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    Acronym: 

    ACTRN/NCT /ethics: 

    NCT03102320; Ethics# 127.17

    Scientific title: 

    Phase 1b multi-indication study of anetumab ravtansine in mesothelin expressing advanced solid tumors (ARCS-Multi).

    Summary of trial and patient characteristics

    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase I Tumour Stream Solid Tumours
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date
    Molecular Target Anticipated End Date
    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase I
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Solid Tumours
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date
    Anticipated End Date

    Trial Summary

    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 cholangiocarinoma 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.

    Lay Summary

    Phase 1b multi-indication study of anetumab ravtansine in mesothelin expressing advanced solid tumors (ARCS-Multi).

    Sponsor / Cooperative group

    Bayer

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Chris Karapetis Recruiting