An Open Label Phase I/II Study of Humanized Human Milk Fat Globule-1 (THEREX) in Patients With Locally Advanced or Metastatic Breast Cancer Following Prior Anthracycline and Taxane Therapy
- Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with
locally advanced or metastatic breast cancer previously treated with anthracycline and
- Determine the maximum tolerated dose and appropriate schedule of this drug in these
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the tumor response rate, progression-free survival, and median survival of
patients treated with this drug.
- Analyze immunological markers for evaluation of disease status (e.g., in vitro analysis
of antibody-dependent cellular cytotoxicity, natural killer cell activity, complement
depletion, and tumor markers CA 15.3 and CEA) in patients treated with this drug.
OUTLINE: This is a dose-escalation, open-label, nonrandomized, multicenter study.
- Phase I: Patients receive monoclonal antibody HuHMFG1 IV over 1-3 hours once every 3
weeks for doses 1 and 2. All subsequent dose intervals are based on individual
half-life value of the drug. Patients receive at least 6 doses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuHMFG1 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II:Patients receive monoclonal antibody HuHMFG1 as above at the MTD. Patients are
followed at 28 days.
PROJECTED ACCRUAL: Approximately 3-40 patients (3-15 patients for phase I and 19-25 patients
for phase II) will be accrued for this study within approximately 12 months.
Masking: Open Label, Primary Purpose: Treatment
Mark D. Pegram, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|