CompletedPhase 1NCT03490669

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.

Checked against the public recordLast updated Apr 5, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations7
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
AstraZeneca
Interventions being studied
Biological: MSC-1
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • HonorHealthScottsdale, Arizona
  • START MidWestGrand Rapids, Michigan
  • Memorial Sloan Kettering Cancer Center- MonmouthMiddletown, New Jersey
  • Memorial Sloan Kettering Cancer Center- WestchesterHarrison, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Princess Margaret Cancer CenterToronto, Ontario
  • Hospital Universitario Vall d'HebronBarcelona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 5, 2024. Always confirm current availability with the study team.

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