Adapting To Oncology Study Needs: Flexibility In Phase I ADC Drug Development

The collaboration between a sponsor and Worldwide, a CRO, focused on a Phase I study of an antibody-drug conjugate (ADC) targeting advanced/metastatic solid tumors, with a particular emphasis on non-small cell lung cancer. The study's primary objectives were to assess the ADC's safety, tolerability, and preliminary antitumor activity using a 3+3 dose-escalation design across 15 U.S. sites. Key challenges included rapid cohort enrollment, frequent protocol modifications, site identification, patient recruitment, and investigator hesitance due to the novelty of ADCs.

Worldwide tackled these challenges through strategic site selection and by fostering strong relationships with site teams and investigators. They utilized existing site alliances and maintained open communication with both sites and the sponsor to efficiently manage protocol amendments and adhere to tight timelines. By educating investigators about ADC trials, Worldwide enhanced their engagement and confidence, thereby improving patient recruitment.

The study achieved notable successes, such as enrolling the first patient within six weeks, accelerating cohort enrollment, and activating all 17 sites ahead of schedule. The adaptive protocol design allowed for a targeted investigation of specific tumor indications, which bolstered investigator involvement and improved communication. Worldwide's comprehensive approach not only optimized enrollment success but also significantly reduced timelines, earning commendation from the sponsor for their effective management and execution of the study.