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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2019-09-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Solid Tumors Pancreatic Cancer Non Small Cell Lung Cancer Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Open-Label

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Multiple dose levels of MSC-1 treatment once every 3 weeks

Group Type EXPERIMENTAL

MSC-1

Intervention Type BIOLOGICAL

humanized monoclonal antibody for intravenous administration

Dose Expansion

MSC-1 treatment at the recommended Phase 2 dose once every 3 weeks

Group Type EXPERIMENTAL

MSC-1

Intervention Type BIOLOGICAL

humanized monoclonal antibody for intravenous administration

Interventions

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MSC-1

humanized monoclonal antibody for intravenous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No