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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490669
Recruitment Status : Terminated (Safety and PK/PD data from Dose Escalation support further development; Dose Expansion canceled)
First Posted : April 6, 2018
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Northern Biologics Inc.

Tracking Information
First Submitted Date  ICMJE February 7, 2018
First Posted Date  ICMJE April 6, 2018
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE May 11, 2018
Actual Primary Completion Date September 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
  • 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. [ Time Frame: Patients will be evaluated for approximately 6 months or until disease progression ]
    Assessment of frequency & severity of adverse events
  • Assess the preliminary anti-tumor activity of MSC-1 monotherapy [ Time Frame: Patients will be evaluated for approximately 6 months or until disease progression ]
    Determine objective response rate (ORR)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
  • Confirm safest dose of MSC-1 for further study [ Time Frame: Patients will be evaluated for approximately 6 months or until disease progression ]
    Assessment of adverse events
  • Characterize the PK of MSC-1 [ Time Frame: Patients will be evaluated before and after each dose of MSC-1 for approximately 6 months or until disease progression. PK will be evaluated more frequently for the first 2 cycles of treatment. ]
    Serum levels of MSC-1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety, PK, PD, Immunogenicity & Antitumor Activity of MSC-1 in Patients With Adv Solid Tumors
Official Title  ICMJE A Phase 1 Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MSC-1 in Patients With Advanced Solid Tumors
Brief Summary

This is a 2-part study to evaluate the safety and antitumor 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 Tumors.

In part 1, multiple dose levels of MSC-1 in patients with Advanced Solid Tumors will be studied to determine the recommended dose for further evaluation of safety and efficacy in Part 2.

Detailed Description

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 tumors. 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 tumor microenvironment as well as promoting the activity of cancer-initiating cell(s) (CICs). LIF is highly expressed in a subset of tumors across multiple solid tumor types.

During dose escalation, patients with Advanced Solid Tumors 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 tumors (NSCLC, Ovarian Cancer, Pancreatic Cancer), and a cohort of mixed Solid Tumors (referred to as the "basket cohort"), may be treated at the recommended expansion dose to further characterize the safety, tolerability, PK, PD and anti-tumor activity of MSC-1.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Open-Label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Pancreatic Cancer
  • Non Small Cell Lung Cancer
  • Ovarian Cancer
Intervention  ICMJE Biological: MSC-1
humanized monoclonal antibody for intravenous administration
Study Arms  ICMJE
  • Experimental: Dose Escalation
    Multiple dose levels of MSC-1 treatment once every 3 weeks
    Intervention: Biological: MSC-1
  • Experimental: Dose Expansion
    MSC-1 treatment at the recommended Phase 2 dose once every 3 weeks
    Intervention: Biological: MSC-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 2, 2020)
41
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2018)
130
Actual Study Completion Date  ICMJE September 23, 2019
Actual Primary Completion Date September 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (All patients):

  • Confirmed Advanced Unresectable Solid Tumor
  • Measurable disease by RECIST 1.1 by CT or MRI
  • Documented disease progression on or following last line of therapy
  • Archival tumor sample for submission
  • ECOG performance status 0 or 1
  • Resolution of all acute, reversible toxic effects of prior therapy or surgical procedures to at least grade 1 (except alopecia and peripheral neuropathy to at least grade 2)
  • Adequate organ function
  • A limited number of patients enrolled in Dose Escalation may be required to agree to pre- and on-treatment tumor biopsies

Inclusion Criteria (Dose Expansion patients only)

  • LIF- High NSCLC, Ovarian Cancer, or Pancreatic Cancer for the tumor-specific cohorts or Advanced Solid Tumor for the basket cohort as assessed by tumor tissue evaluation by IHC
  • All patients enrolled in Dose Expansion must agree to undergo pre- and on-treatment tumor biopsies

Exclusion Criteria (All Patients):

  • Systemic anti-cancer therapy within 4 weeks or 5 half-lives prior to study entry
  • Previous or concurrent malignancy that could affect compliance with protocol or interpretation of results
  • Clinically significant, unstable cardiovascular or pulmonary disease as specified in detail in the study protocol
  • History of acquired or congenital immunodeficiency syndrome or receiving immunosuppressive therapy
  • Uncontrolled infections or serologically positive HIV or hepatitis B or C infection
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or interfere with interpretation of study results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03490669
Other Study ID Numbers  ICMJE MSC-1-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Northern Biologics Inc.
Study Sponsor  ICMJE Northern Biologics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Wasserman, MD Northern Biologics
PRS Account Northern Biologics Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP