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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03490669
Other study ID # MSC-1-101
Secondary ID 2017-003320-79
Status Completed
Phase Phase 1
First received
Last updated
Start date May 21, 2018
Est. completion date September 23, 2019

Study information

Verified date April 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date September 23, 2019
Est. primary completion date September 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
MSC-1
humanized monoclonal antibody for intravenous administration

Locations

Country Name City State
Canada Princess Margaret Cancer Center Toronto Ontario
Spain Hospital Universitario Vall d'Hebron Barcelona
United States START MidWest Grand Rapids Michigan
United States Memorial Sloan Kettering Cancer Center- Westchester Harrison New York
United States Memorial Sloan Kettering Cancer Center- Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States HonorHealth Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
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 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
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
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