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  • AK112-101

    Acronym: 

    AK112-101

    ACTRN/NCT /ethics: 

    NCT04047290

    Scientific title: 

    A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 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, Metastatic or Widespread
    Sex Both Anticipated Start Date 2019-08-15
    Molecular Target Anticipated End Date 2022-12-30
    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, Metastatic or Widespread
    Anticipated Start Date 2019-08-15
    Anticipated End Date 2022-12-30

    Trial Summary

    This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, 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 AK112 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK112 as a single agent at the MTD or RP2D.

    Lay Summary

    A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 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 Dr Anna Mislang Recruiting