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

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ClinicalTrials.gov Identifier: NCT03490669
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Northern Biologics Inc.

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.


Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Pancreatic Cancer Non Small Cell Lung Cancer Ovarian Cancer Biological: MSC-1 Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Open-Label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation
Multiple dose levels of MSC-1 treatment once every 3 weeks
Biological: MSC-1
humanized monoclonal antibody for intravenous administration

Experimental: Dose Expansion
MSC-1 treatment at the recommended Phase 2 dose once every 3 weeks
Biological: MSC-1
humanized monoclonal antibody for intravenous administration




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490669


Contacts
Contact: Kim Hoffman +1-610-310-8245 khoffman@northernbiologics.com

Locations
United States, New York
Memorial Sloan Kettering Cancer Center- Westchester Recruiting
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Northern Biologics Inc.
Investigators
Study Director: Naimish Pandya, MD Northern Biologics Inc.

Additional Information:
Responsible Party: Northern Biologics Inc.
ClinicalTrials.gov Identifier: NCT03490669     History of Changes
Other Study ID Numbers: MSC-1-101
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases