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



Status:Recruiting
Conditions:Lung Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/13/2019
Start Date:May 11, 2018
End Date:July 31, 2020
Contact:Kim Hoffman
Email:khoffman@northernbiologics.com
Phone:+1-610-310-8245

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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

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.

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.

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
We found this trial at
6
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Grand Rapids, Michigan 49503
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500 Westchester Avenue
Harrison, New York 10604
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480 Red Hill Road
Middletown, New Jersey 07748
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Scottsdale, Arizona 85258
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