NEW YORK – CytoDyn said Monday that, following a meeting with the US Food and Drug Administration, it is gearing up to study its investigational CCR5 agonist leronlimab combined with trifluridine, tipiracil (TAS-102), and bevacizumab in patients with advanced CCR5-positive, microsatellite stable colorectal cancer.
In its meeting with the FDA, Vancouver, Washington-based CytoDyn sought alignment with regulators on dosing plans for its Phase II trial. Now, the firm says it will proceed by submitting a final study protocol to the agency and officially engaging a clinical research organization for the trial, among other pretrial activities.
Through the Phase II trial, CytoDyn plans to study roughly 60 patients' overall response rates when they receive leronlimab — either in 350-milligram or 700-milligram doses – plus TAS-102 and bevacizumab.
To be eligible for the trial, metastatic colorectal cancer patients must have received prior chemotherapy, anti-VEGF therapy, and anti-EGFR therapy, if applicable. Patients will have their tumors tested for CCR5 expression with immunohistochemistry and for microsatellite stability using either immunohistochemistry or next-generation sequencing.
"[We] remain on track to commence our oncology trial in the coming months," CytoDyn CEO Jacob Lalezari said in a statement. "Advancing leronlimab in the oncology indication has been an important priority for our team as we progress CytoDyn's clinical pipeline."
CytoDyn is also evaluating leronlimab in other indications beyond cancer as well as in a basket trial across 22 CCR5-positive solid tumor types.