A Phase I, Open-Label Study of MOXR0916 in Patients With Locally Advanced or Metastatic Solid Tumours

Official Title

A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF MOXR0916 ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT TO PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Summary:

This is a first-in-human, Phase I, open-label, multicentre, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in patients with locally advanced or metastatic solid tumours that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. The planned duration of the study is approximately 3 years.

Trial Description

Primary Outcome:

  • Incidence of adverse events graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
  • Incidence of dose-limiting toxicities (DLTs)
Secondary Outcome:
  • Maximum tolerated dose (MTD)
  • Pharmacokinetic parameters derived from serum MOXR0916 concentrations
  • Pharmacokinetic parameters derived from serum MOXR0916 concentrations: clearance, volume of distribution
  • Incidence of anti-MOXR0916 antibodies
  • Objective response determined using RECIST v1.1
  • Duration of objective response determined using RECIST v1.1
  • Progression-free survival determined using RECIST v1.1

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society