A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer
An open-label, multi-dose, single-arm, multi-center, Phase 1, dose-escalation study will be
conducted to define the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics
(PK), immunogenicity, and potential antitumor activity of MGA271 in patients with refractory
cancer that expresses B7-H3.
Patients will be monitored for a minimum of four weeks after administration of the final
dose of MGA271. Study assessments will include adverse event (AE) monitoring,
electrocardiogram (ECG) monitoring, PK analysis of serum MGA271, determination of the serum
concentration of soluble MGA271 and tumor markers, and an assessment of potential
anti-MGA271 antibody [human anti-human antibody (HAHA)] response.
Tumor response assessments using Study Day 43 CT scans or MRI will be performed
approximately six weeks after the first MGA271 dose for each patient. Patients with evidence
of clinical benefit (partial or complete response or stable disease by RECIST or RANO
Response criteria) will be allowed to continue therapy at the same dose, or at a reduced
dose if warranted by dose limiting toxicity (DLT) or significant AE in Cycle 1. Subsequent
cycles which will begin on Study Day 50 will consist of MGA271 administration on Study Days
1, 8, and 15 of each 28-day cycle, with tumor evaluation every other cycle. Responding
patients may receive continued antibody therapy until evidence of progression of disease is
documented or the patient experiences DLT.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Yes
Stanford J Stewart, MD
Study Director
MacroGenics
United States: Food and Drug Administration
CP-MGA271-01
NCT01391143
July 2011
January 2014
Name | Location |
---|---|
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Hospital of the University of Pennsylvania/Abramson Cancer Center | Philadelphia, Pennsylvania 19104 |