Clinical-stage biopharmaceutical company BioEclipse Therapeutics has initiated patient enrolment in a Phase I dose-escalation trial of CRX100 for treating refractory solid tumours.
CRX100 is developed with technology licenced from Stanford University. The therapy combines activated immune cells called cytokine-induced killer (CIK) cells with an oncolytic virus.
Participants are currently being enrolled at HonorHealth Research Institute in Scottsdale, Arizona, US.
This is the first-in-human study of the intravenously delivered CRX100, which can potentially target and kill various cancer types and tackle disease recurrence.
BioEclipse president and CEO Pamela Contag said: “CRX100 is a single therapeutic designed to attack multiple characteristics of numerous cancer types.
“With this new approach, BioEclipse is poised to address the substantial and growing unmet need for treatment options for solid tumours and metastatic disease considered by many to be untreatable.”
The open-label trial will evaluate the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in around 24 adult participants with advanced solid tumours non-responsive to the standard of care. They will be given up to two doses of CRX100.
Six potential cancer indications are the target of the trial. They include triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer and gastric cancer.
Effect of CRX100 on a subject’s tumour progression and overall immune response will form the trial’s secondary endpoints.
BioEclipse is now focusing on recurring cancer treatment with a distinctive multi-mechanistic approach that could address cancers considered untreatable.
HonorHealth Research Institute Breast and Gynecological Early Phase Clinical Trials director and study’s principal Investigator Jasgit Sachdev said: “Refractory disease is challenging to treat.
“Data from preclinical models assessing the treatment approached used by CRX100 suggest the potential to address several types of cancer and bring hope to patients with otherwise poor prognosis.”