Have you or your loved ones been diagnosed with advanced solid tumors?

You may be eligible to participate in a advanced solid tumors clinical trial.

Have you or your loved ones been diagnosed with advanced solid tumors? You may be eligible to participate in a advanced solid tumors clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Advanced Solid Tumors Clinical Trial in Grand Rapids MI

NCT03490669 | Phase 1 | Interventional

Have you or your loved ones been diagnosed with advanced solid tumors?

You may be eligible to participate in a advanced solid tumors clinical trial.

Have you or your loved ones been diagnosed with advanced solid tumors? You may be eligible to participate in a advanced solid tumors clinical trial.

Terminated

Male & Female

18 Years +

This study has recruited 41 Participants

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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Details for the study

Brief Title

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

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

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.

Treatments and/or Procedures

MSC 1

humanized monoclonal antibody for intravenous administration

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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.

Assessment of frequency & severity of adverse events

Patients will be evaluated for approximately 6 months or until disease progression

Primary

Assess the preliminary anti-tumor activity of MSC-1 monotherapy

Determine objective response rate (ORR)

Patients will be evaluated for approximately 6 months or until disease progression

Secondary

Characterize the PK of MSC-1

Serum levels of MSC-1

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.

Secondary

Confirm safest dose of MSC-1 for further study

Assessment of adverse events

Patients will be evaluated for approximately 6 months or until disease progression

Study 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