Study to Evaluate Safety, PK, PD, Immunogenicity & Antitumour Activity of MSC-1 in Patients With Adv Solid Tumours

Official Title

A Phase 1 Multicentre, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumour Activity of MSC-1 in Patients With Advanced Solid Tumours

Summary:

This is a 2-part study to evaluate the safety and antitumour activity of MSC-1. MSC-1 is a first-in-class, humanized monoclonal antibody (IgG1) which binds to the immunosuppressive human cytokine Leukemia Inhibitory Factor (LIF), and is intended to treat adult patients with Advanced Solid Tumours. In part 1, multiple dose levels of MSC-1 in patients with Advanced Solid Tumours will be studied to determine the recommended dose for further evaluation of safety and efficacy in Part 2.

Trial Description

Primary Outcome:

  • Evaluate the safety and tolerability of MSC-1 and determine the recommended dose for MSC-1 monotherapy for further evaluation in the expansion part of the study.
  • Assess the preliminary anti-tumour activity of MSC-1 monotherapy
Secondary Outcome:
  • Confirm safest dose of MSC-1 for further study
  • Characterize the PK of MSC-1
MSC-1 is a first-in-class, humanized monoclonal antibody (IgG1) which binds to the immunosuppressive human cytokine Leukemia Inhibitory Factor (LIF), and is intended to treat adult patients with advanced solid tumours. LIF is a pleiotropic cytokine involved in many physiological and pathological processes including the promotion of an immunosuppressive environment. In cancer, it is hypothesized that LIF expressing malignancies co-opt this activity, creating an immunosuppressive tumour microenvironment as well as promoting the activity of cancer-initiating cell(s) (CICs). LIF is highly expressed in a subset of tumours across multiple solid tumour types. During dose escalation, patients with Advanced Solid Tumours will be treated with MSC-1 with the primary objective of determining the safety and tolerability of MSC-1 and defining an appropriate dose for further evaluation in dose expansion. MSC-1 will be administered intravenously (IV) until disease progression, unmanageable toxicity, withdrawal of consent or study termination. In dose expansion, up to 4 parallel cohorts of patients with LIF-High tumours (NSCLC, Ovarian Cancer, Pancreatic Cancer), and a cohort of mixed Solid Tumours (referred to as the "basket cohort"), may be treated at the recommended expansion dose to further characterize the safety, tolerability, PK, PD and anti-tumour activity of MSC-1.

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