Australia-based Alchemia has started patient enrolment of the new clinical trial of HA-Irinotecan and Erbitux (cetuximab) called the CHIME trial.
Conducted as an investigator-sponsored trial and jointly supported by Alchemia and Merck Serono, the trial is being led by principal investigator, associate professor Peter Gibbs.
Alchemia chief scientific officer Tracey Brown said: "The commencement of this clinical trial achieves another milestone in the clinical development of HA-Irinotecan as this study will be the first use of a HyACT drug within an antibody-containing regimen, which is the current and future standard of care for cancer patients."
The trial’s primary objective is to assess the safety of Alchemia’s lead HyACT drug, HA-Irinotecan, as part of the FOLFIRI treatment regimen, in combination with Erbitux.
Scheduled to run for about 24 months, the trial will enrol around 50 patients who are candidates for second-line treatment of metastatic colorectal cancer (mCRC) and it will take place at six to ten sites around Australia.
Associate professor Gibbs said: "The goal of this trial is to demonstrate that HA-Irinotecan, when administered as part of the FOLFIRI regimen, is well-tolerated when used in combination with Erbitux, which is a current standard of care in the treatment of metastatic colorectal cancer patients."
The company’s lead asset HA-Irinotecan is in a pivotal Phase III clinical trial to treat metastatic colorectal cancer, which is one of the most common cancers in the world.
In November 2013, the company said that the Data Safety Monitoring Board (DSMB) concluded a scheduled review of patient experience and safety in its ongoing pivotal Phase III clinical trial of HA-Irinotecan in metastatic colorectal cancer.
The company said that the trial continues to treat patients safely, thus permitting them to continue the trial to its completion.