A Study to Assess Safety and Pharmacokinetics of MOXR0916 in Participants 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 Tumours

Summary:

This is a first-in-human, Phase 1, open-label, multicentre, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR0916 administered intravenously in participants 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. This study will consist of a screening period, an initial treatment period, a re-treatment period (for participants who discontinue MOXR0916 after demonstration of prolonged clinical benefit), and a post-treatment follow-up period. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage. The planned duration of the study is approximately 3 years.

Trial Description

Primary Outcome:

  • Percentage of Participants With Dose Limiting Toxicities (DLTs)
  • Percentage of Participants With Adverse Events (AEs) by Severity as Graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
Secondary Outcome:
  • Maximum Tolerated Dose (MTD) of MOXR0916
  • Recommended Phase II Dose of MOXR0916
  • Percentage of Participants With Anti-MOXR0916 Antibodies
  • Number of Cycles of MOXR0916 Treatment Received
  • Mean MOXR0916 Dose Administered During Study
  • Area Under the Serum Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of MOXR0916
  • Maximum Observed Serum Concentration (Cmax) of MOXR0916
  • Minimum Observed Serum Concentration (Cmin) of MOXR0916
  • Serum Clearance (CL/F) of MOXR0916
  • Apparent Volume of Distribution at Steady State (Vss) of MOXR0916
  • Percentage of Participants With Objective Response as Determined Using Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST v1.1)
  • Duration of Objective Response (DOR) as Determined Using RECIST v1.1
  • Progression-free Survival (PFS) as Determined Using RECIST v1.1
  • Percentage of Participants With Objective Response as Determined Using Modified RECIST
  • DOR as Determined Using Modified RECIST
  • PFS as Determined Using Modified RECIST
  • Overall Survival (OS)

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