Safety Study of MGA271 in Refractory Cancer
A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer
1 other identifier
interventional
179
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Jul 2011
Longer than P75 for phase_1 prostate-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 7, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2019
CompletedFebruary 8, 2022
February 1, 2022
7.8 years
July 7, 2011
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Adverse events, serious adverse events, ECG monitoring, adrenal function monitoring, monitoring for development of anti-drug antibodies
Study Day 50 or 28 days after last infusion
Secondary Outcomes (1)
Maximum tolerated dose
Study Day 50 or 28 days after last infusion
Other Outcomes (1)
Tumor response
Every 8 weeks
Study Arms (1)
MGA271
EXPERIMENTALFc-optimized, humanized monoclonal antibody
Interventions
Up to 9 dose escalation cohorts will be enrolled to determine the maximum tolerated dose of MGA271. Patients with evidence of clinical benefit will be allowed to continue therapy at the same dose once per week for 3 weeks out of every 4-week cycle until documented progression. Patients treated in the Expansion Segment at the maximum administered dose will receive weekly, uninterrupted infusions of MGA271 in 8 week cycles for up to 12 cycles.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MacroGenicslead
Study Sites (12)
UCLA Hematology-Oncology Clinic
Los Angeles, California, 90095, United States
Yale Cancer Center
New Haven, Connecticut, 06520, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Neely Center for Clinical Cancer Research, Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Carolina Biooncology Institute
Huntersville, North Carolina, 28078, United States
Hospital of the University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
MacroGenics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2011
First Posted
July 11, 2011
Study Start
July 1, 2011
Primary Completion
April 18, 2019
Study Completion
April 18, 2019
Last Updated
February 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share