Finding studies
Finding studies
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Lead
ImmunoGen, Inc.
OBJECTIVES: Primary * 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. Secondary * 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 unacceptable toxicity. 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 pharmacokinetic studies. After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
