Kolltan Pharmaceuticals has started Phase Ib portion of its KTN3379 clinical trial programme in combination with multiple targeted therapies.
The Phase Ib trial is evaluating KTN3379, a human monoclonal antibody, in specific cancer populations and in combination with the currently approved cancer drugs cetuximab, erlotinib, vemurafenib and trastuzumab.
The company, which is focused on the discovery and development of new antibody-based drugs targeting receptor tyrosine kinases (RTKs), said that these combinatorial agents were selected based on preclinical studies.
First patient was treated at the Sarah Cannon Research Institute in Nashville, where the trial is being conducted by principal investigator Dr Todd Bauer.
The trial will also be conducted at Sarah Cannon Research Institute’s Denver site with Dr Gerald Falchook serving as principal investigator.
KTN3379 is designed to block the activity of ErbB3, an RTK that belongs to the epidermal growth factor receptor, or EGFR, family.
ErbB3 is believed to be a major receptor regulating cancer cell growth and survival, and it is expressed in many cancers including head and neck, breast, colorectal, lung, gastric, ovarian and melanoma.
Kolltan Pharmaceuticals president and chief executive officer Jerry McMahon said: "The initiation of the Phase Ib portion of our KTN3379 clinical programme is critical for the evaluation of patients with several tumour types using selected combinations of targeted therapies.
"We plan to use the data from this portion of our trial to select combinations and indications to move into larger Phase II trials next year. We are delighted to have Sarah Cannon partner with us in conducting this study."
Data secured from the recently completed dose escalation portion of the Phase I clinical trial have been selected for an oral presentation at the upcoming 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona.
The company said that the presentation will describe results from the dose escalation portion of the Phase I trial programme that focused on pharmacokinetics, biomarkers and safety, as well as discuss the preclinical data to support the expansion into Phase Ib combination trials.