An emerging oncology biotech developing next-generation bispecific antibody therapies partnered with Catalyst Oncology to manage a complex gastrointestinal (GI) oncology study. The biotech had recently acquired the investigational therapy and was preparing to launch its first US-based clinical program. The sponsor needed a CRO that could offer strategic insight, full-service support and the flexibility to adapt in real time.
The Challenge
Originally awarded as a small Phase Ib/II study with 10 sites and 40 patients, the trial underwent a dramatic transformation mid-startup following recommendations to revise the study design and enrollment criteria to a more robust study. The biotech’s strategic shift to pursue a registrational Phase II/III design significantly increased the trial’s scope and complexity, expanding it to over 30 sites and 150 patients. While these changes ultimately optimized trial outcomes, they triggered multiple protocol amendments—including several during start-up—that introduced risk. The expanded scope also led to rising trial costs and mounting financial pressure for the sponsor.
The Solution
Fully committed to supporting the sponsor’s goals, Catalyst remained flexible amid ongoing study shifts—continuing to activate sites, sustain momentum, and minimize delays.
To address potential enrollment challenges, Catalyst proactively recommended updating the eligibility criteria and adding a crossover arm to allow patients on the control arm to access the investigational therapy. These adjustments enhanced patient appeal and strengthened site engagement.
Catalyst also implemented a flexible commercial structure that aligned payments with enrollment milestones—demonstrating a deep commitment to the sponsor’s needs to manage cashflow, and to linking cost with trial success.
The Outcome
Catalyst’s strategic input and operational agility enabled the sponsor to complete enrollment ahead of revised expectations. A recent interim analysis revealed a positive treatment effect, positioning the sponsor to pursue Breakthrough Therapy Designation (BTD) with the FDA and a potential registrational submission. The study remains on track to complete within or ahead of the originally scoped timeline—despite its dramatic expansion in scope and complexity.
The sponsor has grown to trust Catalyst as a true partner, with the engagement evolving from a transactional relationship into a collaborative alliance.
