ImmunoGen has commenced the Phase I trial of IMGN853 in ovarian cancer and other solid tumours over-expressing its folate receptor target, including non-small cell lung cancer.
The IMGN853 is a TAP compound that contains an ImmunoGen FOLR1-targeting antibody attached to the company's potent cell-killing agent, DM4.
The multi-centre, first-in-human trial, which will enrol 64 patients, is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anticancer activity of the TAP compound.
ImmunoGen vice president and chief medical officer James O'Leary said the trial is expected to provide key information needed to define the registration path for IMGN853.
"The study protocol allows for the use of single-patient cohorts for evaluation of the lower dose levels, which should accelerate the pace of advancement to higher doses and to the trial's expansion phase. In the expansion phase, IMGN853 will be evaluated as a treatment for specific types of FOLR1-overexpressing tumors," O'Leary added.
"These findings should enable us to make decisions needed to advance IMGN853 into later-stage clinical testing."
The company plans to evaluate the activity of the compound in disease-specific patient cohorts, once the maximum tolerated dose (MTD) of IMGN853 is established.
Three expansion cohorts will evaluate the pharmacodynamics and antitumor activity of IMGN853 at the MTD in patients with specific types of cancers such as Epithelial ovarian cancer (EOC) that is refractory/resistant to platinum, EOC that is relapsed/refractory to conventional treatments and Adenocarcinoma NSCLC that is relapsed/refractory to conventional treatments.