As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing
chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for
delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of
hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in
optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific
example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced
efficacy in both nonclinical and early clinical studies.
The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm
trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild
type metastatic colorectal cancer. The study objectives are to confirm the safety and
efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic
colorectal cancer patients.
It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent
treatment and follow up; thus the trial will run for approximately 2-3 years.