AMG 404 in Patients With Advanced Solid Tumours.

Official Title

A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients With Advanced Solid Tumours

Summary:

To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1 and inhibits its engagement with ligands, in patients with advanced solid tumours.

Trial Description

Primary Outcome:

  • Subject incidence of Dose limiting toxicities (DLTs)
  • Subject incidence of treatment emergent adverse events
  • Subject incidence of treatment related adverse events
  • Subject incidence of changes in vital signs
  • Subject incidence of clinical laboratory tests
Secondary Outcome:
  • QT interval relationship
  • Subject incidence of anti-AMG 404 antibodies
  • Maximum observed concentration (Cmax) of AMG 404
  • Time of maximum observed concentration (Tmax) of AMG 404
  • Area under the serum concentration-time curve (AUC) of AMG 404

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society