A Phase I Study to Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single Intravenous Infusion Once Every Three Weeks to Subjects With Solid Tumors
- Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid
DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or
metastatic colorectal cancer, pancreatic cancer, or other solid tumors.
- Determine the qualitative and quantitative toxicities of this drug in these patients.
- Characterize the pharmacokinetics of this drug in these patients.
- Describe any antitumor activity of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation study.
Patients receive maytansinoid DM4-conjugated humanized monoclonal antibody huC242 IV over
4-5 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of maytansinoid DM4-conjugated humanized
monoclonal antibody huC242 until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 6 patients experience dose-limiting
toxicity. Up to 15 patients are treated at the MTD.
Patients undergo blood collection at baseline and periodically during study for
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
for the duration of the trial
Alain Mita, MD
Institute for Drug Development
United States: Food and Drug Administration
|South Texas Accelerated Research Therapeutics||San Antonio, Texas 78229|
|UT Health Science Center||San Antonio, Texas 78245-3217|