Boston Biomedical has dosed the first patient in CanStem303C, a new global Phase III study investigating napabucasin in combination with standard of care (FOLFIRI) in patients with previously treated metastatic colorectal carcinoma (mCRC).
Around 1.4 million patients are diagnosed with colorectal cancer every year, making the disease the fourth leading cause of cancer-related deaths annually, with almost 700,000 deaths reported worldwide.
An estimated 50% of all colorectal cancer patients will experience disease recurrence.
Boston Biomedical chief medical officer, president and CEO and Sumitomo Dainippon Pharma Group global oncology head Chiang J. Li said: “Early clinical data for napabucasin in combination with FOLFIRI in advanced colorectal cancer has demonstrated encouraging anti-tumour activity even in FOLFIRI-pretreated patients, so we are eager to understand more deeply its potential therapeutic benefits in this difficult-to-treat cancer.
“This milestone study is evidence of our commitment to uncover the full potential of cancer stemness pathway inhibition, and develop innovative second-line options for the colorectal cancer patient population.”
Patients in this global Phase III study will be randomised in a 1:1 ratio to receive either two daily doses of 240mg napabucasin, an orally administered investigational agent intended to inhibit cancer stemness pathways by targeting STAT3, as well as biweekly FOLFIRI or biweekly FOLFIRI alone.
The trial also enables the addition of bevacizumab per direction by the study investigator.
The study will see enrolment of a total of 1,250 patients.
The primary endpoint of the study is overall survival, while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), safety and quality of life.
Overall survival, PFS, ORR and DCR analyses will be conducted in the general study population, as well as in biomarker-positive patients.