An innovative biotech company is developing a next-generation antibody-drug conjugate (ADC) designed to treat non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and represents a high unmet medical need. When the company faced compressed timelines, Worldwide was engaged to design and deliver a large, global first-in-human (FIH) study, rapidly evolving the trial from a traditional 3+3 all-comers solid tumor dose-escalation design into a global dose-escalation and expansion trial aligned with Project Optimus principles.
Read our case study to learn how Worldwide:
- Implemented a backfilling Bayesian optimal interval design model
- Enrolled more than 250 patients and accelerated timelines
- Expanded the trial beyond the U.S., activating 55 sites across seven countries
- Successfully completed dose escalation to enroll ahead of schedule and gain FDA Fast Track designation
