NCT00352131

Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: ImmunoGen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as maytansinoid DM4-conjugated humanized monoclonal antibody huC242, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body.

Detailed description

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.

Conditions

• Non-colorectal Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	HuC242-DM4	Dose escalation study to define maximum tolerated dose. Doses will vary per cohort. Patients will receive an IV infusion once every three weeks.

Timeline

• Start date: 2005-02-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-07-14
• Last updated: 2010-03-17

Locations

2 sites across 1 country: United States