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

Sponsor
Northern Biologics Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03490669
Collaborator
(none)
41
Enrollment
7
Locations
2
Arms
16.4
Actual Duration (Months)
5.9
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: MSC-1
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Open-LabelOpen-Label
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 11, 2018
Actual Primary Completion Date :
Sep 23, 2019
Actual Study Completion Date :
Sep 23, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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. [Patients will be evaluated for approximately 6 months or until disease progression]

    Assessment of frequency & severity of adverse events

  2. Assess the preliminary anti-tumor activity of MSC-1 monotherapy [Patients will be evaluated for approximately 6 months or until disease progression]

    Determine objective response rate (ORR)

Secondary Outcome Measures

  1. Confirm safest dose of MSC-1 for further study [Patients will be evaluated for approximately 6 months or until disease progression]

    Assessment of adverse events

  2. Characterize the PK 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.]

    Serum levels of MSC-1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 HonorHealth Scottsdale Arizona United States 85258
2 START MidWest Grand Rapids Michigan United States 49546
3 Memorial Sloan Kettering Cancer Center- Monmouth Middletown New Jersey United States 07748
4 Memorial Sloan Kettering Cancer Center- Westchester Harrison New York United States 10604
5 Memorial Sloan Kettering Cancer Center New York New York United States 10065
6 Princess Margaret Cancer Center Toronto Ontario Canada M5G 1Z5
7 Hospital Universitario Vall d'Hebron Barcelona Spain 08035

Sponsors and Collaborators

  • Northern Biologics Inc.

Investigators

  • Study Director: Robert Wasserman, MD, Northern Biologics

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Northern Biologics Inc.
ClinicalTrials.gov Identifier:
NCT03490669
Other Study ID Numbers:
  • MSC-1-101
First Posted:
Apr 6, 2018
Last Update Posted:
Jan 6, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 6, 2020