Accelerating a Global, FIH ADC Therapy Trial for Lung Cancer

This case study outlines the execution of a global first-in-human (FIH) study for a novel antibody-drug conjugate (ADC) therapy targeting non-small cell lung cancer (NSCLC). Initially designed as a U.S.-only dose escalation trial, the study was adapted to meet the challenges posed by a rapidly evolving competitive landscape and regulatory expectations, particularly the FDA’s Project Optimus initiative. The sponsor engaged Worldwide Clinical Trials to leverage their global reach and expertise in ADC trials. The study protocol was revised to implement a Bayesian optimal interval design, facilitating the enrollment of over 250 patients across multiple countries. This approach allowed for rapid progression through the trial phases, with a focus on dose escalation and cohort management. The outcomes included successful early safety and efficacy signals, positioning the sponsor to transition towards a registration trial. The collaboration emphasized agile problem-solving and direct alignment between Worldwide and the sponsor, enhancing the overall development process.