Project Zero Delay Accelerates Drug’s Path to Clinical Trial
A phase I clinical trial enrolled its first patient only 2 days after FDA clearance of the experimental drug for a first-in-human cancer trial, a milestone that normally takes 3 to 6 months. Investigators from The University of Texas M.D.
A phase I clinical trial enrolled its first patient only 2 days after FDA clearance of the experimental drug for a first-in-human cancer trial, a milestone that normally takes 3 to 6 months. Investigators from The University of Texas M.D. Anderson Cancer Center and pharmaceutical company AstraZeneca have reported their work in the Journal of Clinical Oncology published online on August 3rd.
The joint effort, dubbed Project Zero Delay, is part of a strategic collaboration between the two organizations designed to safely accelerate development of new cancer drugs. The key to Zero Delay was performing most tasks in parallel instead of sequentially, said lead author Razelle Kurzrock, md, professor and chair of M.D. Anderson’s Department of Investigational Therapeutics.
Efficacy and Safety of Zolbetuximab in Gastric Cancer
Zolbetuximab’s targeted action, combined with manageable adverse effects, positions it as a promising therapy for advanced gastric cancer.
These data support less restrictive clinical trial eligibility criteria for those with metastatic NSCLC. This is especially true regarding both targeted therapy and immunotherapy treatment regimens.
