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Clinical Trial Summary

A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.


Clinical Trial Description

This is a , Phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104 in subjects with advanced and metastatic solid tumours. The study comprises of 2 phases: a dose escalation phase and a dose expansion phase. Dose escalation for AK127 will occur using the 3+3+3 model given with a fixed regimen of AK104. Dose expansion will open at the discretion of the Sponsor. ;


Study Design


Related Conditions & MeSH terms

  • Advanced or Metastatic Solid Tumours
  • Neoplasms

NCT number NCT05021120
Study type Interventional
Source Akeso
Contact Baiyong Li
Phone +86 (0760) 8987 3999
Email global.trials@akesobio.com
Status Recruiting
Phase Early Phase 1
Start date October 12, 2021
Completion date April 7, 2025

See also
  Status Clinical Trial Phase
Completed NCT01281592 - A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours Phase 1
Recruiting NCT03658070 - A Study of XY0206 in Subjects With Advanced or Metastatic Solid Tumours Phase 1