CompletedPhase 1NCT01391143

Safety Study of MGA271 in Refractory Cancer

The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.

Checked against the public recordLast updated Feb 8, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations12
SponsorMacroGenics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
MacroGenics
Interventions being studied
Biological: MGA271
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: * Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B7-H3. * Progressive disease during or after last treatment regimen. * Appropriate treatment history for histological entity. * ECOG Performance Status \<= 1. * Life expectancy \>= 3 months. * Measurable disease or evaluable disease with relevant tumor marker elevation. * Acceptable laboratory parameters and adequate organ reserve. Exclusion Criteria: * Major surgery or trauma within four weeks before enrollment. * Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation. * Grade 3 colitis, hepatitis, pneumonitis uveitis, myocarditis, myositis, CNS toxicity or autoimmune related neuromuscular toxicity such as myasthenia gravis associated with the administration of an immune checkpoint inhibitor * Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score \< 6), or resected melanoma in situ are exceptions and do not require a 3 year remission. * Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment. * Vaccination within 2 weeks of enrollment (except for annual flu vaccine). * History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.

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

  • UCLA Hematology-Oncology ClinicLos Angeles, California
  • Yale Cancer CenterNew Haven, Connecticut
  • Moffitt Cancer CenterTampa, Florida
  • The University of ChicagoChicago, Illinois
  • Norton Cancer InstituteLouisville, Kentucky
  • University of MarylandBaltimore, Maryland
  • Neely Center for Clinical Cancer Research, Tufts Medical CenterBoston, Massachusetts
  • Massachusetts General Hospital Cancer CenterBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Carolina Biooncology InstituteHuntersville, North Carolina
  • Hospital of the University of Pennsylvania/Abramson Cancer CenterPhiladelphia, Pennsylvania
  • Sarah Cannon Research InstituteNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 8, 2022. Always confirm current availability with the study team.

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