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A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer, Pancreatic Cancer, Melanoma, Renal Cell Carcinoma, Ovarian Cancer, Colorectal Cancer, Gastric Cancer, Bladder Cancer, Non-small Cell Lung Cancer, Glioblastoma

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Trial Information

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.

Inclusion Criteria:

- Histologically or cytologically confirmed carcinoma, melanoma, or glioblastoma 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:

- Evidence of adrenal insufficiency by rapid Cosyntropin stimulation test (patients
with glioblastoma who have or are receiving steroids in past 4 months will be
exempted from this exclusion).

- 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.

- History of autoimmune disease associated with ipilimumab therapy.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Adverse events, serious adverse events, ECG monitoring, adrenal function monitoring, monitoring for development of anti-drug antibodies

Outcome Time Frame:

Study Day 50 or 28 days after last infusion

Safety Issue:


Principal Investigator

Stanford J Stewart, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

January 2014

Related Keywords:

  • Prostate Cancer
  • Pancreatic Cancer
  • Melanoma
  • Renal Cell Carcinoma
  • Ovarian Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Bladder Cancer
  • Non-Small Cell Lung Cancer
  • Glioblastoma
  • refractory cancer
  • Prostate cancer
  • Pancreatic cancer
  • Melanoma
  • Renal cell carcinoma
  • Ovarian cancer
  • Colorectal cancer
  • Gastric cancer
  • Bladder cancer
  • Non-small cell lung cancer
  • Glioblastoma
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Colorectal Neoplasms
  • Glioblastoma
  • Lung Neoplasms
  • Stomach Neoplasms
  • Melanoma
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms



Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Sarah Cannon Research InstituteNashville, Tennessee  37203
Hospital of the University of Pennsylvania/Abramson Cancer CenterPhiladelphia, Pennsylvania  19104