NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Advanced Solid Tumors, Pancreatic Cancer, Non Small Cell Lung Cancer, Ovarian Cancer

Interventions: MSC-1

Countries: United States, Canada, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (7)

Scottsdale, Arizona, United States
Grand Rapids, Michigan, United States
Middletown, New Jersey, United States
Harrison, New York, United States
New York, New York, United States
Toronto, Ontario, Canada
Barcelona, Spain