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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 5, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AstraZeneca
- Interventions being studied
- Biological: MSC-1
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- (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
- (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.
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.