FDA clears to begin colorectal cancer therapy trial
The US Food and Drug Administration (FDA) has issued a ‘safe to proceed’ letter for Carina Biotech’s investigational new drug (NDA) application to commence a Phase I/IIa clinical trial of CNA3103 to treat advanced colorectal cancer (CRC).
A total of 44 metastatic disease patients who are failing previous lines of chemotherapy and express LGR5 on their cancer cells will be enrolled in the first-in-human Phase I/IIa clinical trial.
The Phase I segment will enroll 24 patients in select centres in Australia.
It will follow a Bayesian Optimal Interval (BOIN) design and each patient will receive ascending doses of chimeric antigen receptor T cells.
This segment will evaluate the tolerability and safety of CNA3103 and also determine its optimal dose.
The Phase II segment will characterize the CNA3103 activity in terms of antitumor response, along with the duration of response and time to disease progression.
CNA3103 is the company’s LGR5-targeted CAR-T therapy candidate.
It demonstrated complete tumor regression and no tumor recurrence after a single administration in pre-clinical studies.
The CAR-T therapy candidate also showed prolonged survival and better tumor access.