Study To Evaluate Safety, PK, PD, Immunogenicity & Antitumor Activity Of MSC-1 In Patients With Adv Solid Tumors

Study Overview

Study to Evaluate Safety, PK, PD, Immunogenicity & Antitumor Activity of MSC-1 in Patients With Adv 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 ⊺sket cohort"), may be treated at the recommended expansion dose to further characterize the safety, tolerability, PK, PD and anti-tumor activity of MSC-1.

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

BIOLOGICAL: MSC-1

MSC-1-101
2017-003320-79 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-02-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-04
First Submitted that Met QC Criteria 2018-03-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-05
First Posted (ACTUAL) 2018-04-06	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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	Measure Description	Time Frame
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
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 Outcome Measures	Measure Description	Time Frame
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record