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Catalyst Oncology FIH Rescue Study

May 29, 2024

A clinical-stage biotech company with a critical startup milestone

Catalyst Oncology transitioned full-service work from a large CRO to help expedite a clinical-stage biotech’s first-in-human (FIH) study. Milestones around first site initiated (FSI) were linked to funding, requiring a flexible and rapid response.

The Sponsor contracted with a big CRO for full-service support of its FIH study. Frustrations grew with the large generalist CRO’s lack of urgency and its team turnover, rigid processes around contracting, and delays in startup. The study’s FSI milestone was critical to both internal goals and a funding round, so the clock was ticking. The Sponsor contacted Catalyst Oncology to see if we could rapidly and fully rescue the work. This study was a Phase I/II Project Optimus optimized design in solid tumors due to enroll 192 patients (30 in escalation) at 30 sites (six in escalation) across the U.S. and Europe.

Catalyst Oncology mobilized our management team to create a top team and stepped in to expedite activities such as:


Catalyst Oncology impact: Catalyst Oncology engaged with the Sponsor, leveraging our values of listening, flexibility, and collaboration to understand current status and key milestones, then accomplished the following:

Leveraged our value of commitment to assess and communicate whether we could mobilize a team quickly enough
Stepped through a robust transition process to seamlessly rescue the project
Beat the Sponsor’s FSI goal

Nine weeks after regulatory pack submission and 12 weeks after the kick-off meeting.