![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » IMMUNOGEN ANNOUNCES TESTING OF ITS HUC242-DM4 COMPOUND
IMMUNOGEN ANNOUNCES TESTING OF ITS HUC242-DM4 COMPOUND
June 28, 2005
ImmunoGen, has announced the initiation of patient dosing with its huC242-DM4 Tumor-Activated Prodrug (TAP) compound, which is in development for the treatment of colorectal, pancreatic, and other cancers that express the CanAg antigen targeted by the compound.
Anthony Tolcher is the principal investigator for this Phase I dose-escalation study, which is underway at the Cancer Therapy and Research Center in San Antonio, Texas. In this study, huC242-DM4 will be administered once every three weeks to patients with refractory CanAg-expressing cancers.
The primary objective of this study is to evaluate the safety and pharmacokinetics of huC242-DM4 in this patient population, and to identify the maximum tolerated dose (MTD) of the compound. Once the MTD is defined, additional patients will be enrolled with tumors that consistently and intensely express CanAg to gain further experience in these patients.
An earlier version of huC242-DM4, called cantuzumab mertansine, was tested clinically and found to be well tolerated at doses that demonstrate evidence of biological activity. In preclinical studies, huC242-DM4 was found to be significantly more active than cantuzumab mertansine with comparable tolerability.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct