Delivering A Registrational GI Trial Through Ongoing Protocol Shifts

An emerging oncology biotechnology company developing next-generation bispecific antibody therapies partnered with Catalyst Oncology to manage a complex gastrointestinal (GI) oncology study. Having recently acquired the investigational therapy, the biotech was preparing to launch its first U.S.-based clinical program and faced multiple challenges, including the need to navigate regulatory requirements, establish study infrastructure, and ensure rapid patient recruitment in a highly competitive therapeutic area.

The sponsor required a clinical research organization (CRO) that could provide strategic guidance, full-service operational support, and the flexibility to adapt in real time to evolving trial demands. Catalyst Oncology collaborated closely with the sponsor to design and execute a tailored clinical strategy, leveraging its expertise in early-phase oncology trials, site relationships, and operational efficiency.

This partnership enabled the biotech to accelerate study start-up, streamline patient enrollment, and maintain high-quality data collection. The case demonstrates how strategic CRO partnerships can facilitate the successful launch of complex oncology programs and support emerging biotechs entering the U.S. clinical landscape.