Pioneering Strategies For Early Phase Oncology Trials

By Erin Finot, Vice President, Immuno-Oncology and Cell & Gene Therapy and Matt Simmons, Senior Director, Oncology Strategy

In oncology drug development, first-in-human (FIH) and early-phase trials serve as crucial stepping stones, offering initial insights into the safety and efficacy of investigational therapies. Adaptive designs have emerged as a transformative approach, enabling mid-course modifications based on real-time data to optimize dosing, streamline protocols, and enhance patient outcomes. By integrating patient-centric strategies, minimizing protocol amendments, and leveraging modeling and simulation, these trials reduce inefficiencies while maintaining scientific rigor.

Project Optimus further revolutionizes early-phase oncology trials by shifting focus from maximum tolerated doses to biologically effective doses, balancing safety and efficacy. The incorporation of patient-reported outcomes (PROs) ensures a holistic assessment of treatment impact, while data-driven methodologies aid in precise dose optimization.

As the field advances, adaptive methodologies and regulatory shifts redefine early-phase oncology trials, promoting efficiency, flexibility, and equitable access. The integration of these strategies not only accelerates development timelines but also ensures that novel treatments reach patients in a timely and effective manner.