Redefining Phase 1 for Cancer Trial: The FDA’s Latest Guidance
Early-phase oncology trials operated under a simple, brutal logic: push the dose until the patient breaks, then step back one notch. While that “maximum tolerated dose” mindset made sense for traditional cytotoxic chemotherapy, modern targeted therapies, biologics, and cell therapies play by entirely different biological rules. At the same time, overly rigid eligibility checklists routinely … Read more