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  • AK105-101

    Acronym: 

    AK105-101

    ACTRN/NCT /ethics: 

    NCT03352531

    Scientific title: 

    Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With Advanced Solid Tumors

    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 2017-12-22
    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 2017-12-22
    Anticipated End Date

    Trial Summary

    This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK105 as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK105 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK105 as a single agent at the MTD or RP2D.

    Lay Summary

    Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With Advanced Solid Tumors

    Sponsor / Cooperative group

    AkesoBio

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Sue Yeend syeend@adelaidecancercentre.com.au 08 8292 2240 Recruiting