An innovative biotech was developing a next-generation antibody-drug conjugate (ADC) for the treatment of non-small cell lung cancer (NSCLC)—the most common form of lung cancer and a disease with high unmet medical need. Initially planning a US-only, first-in-human (FIH) dose escalation, the sponsor pivoted in response to increased competition and evolving regulatory expectations, including the US Food and Drug Administration’s Project Optimus initiative.
With much at stake, the sponsor needed a CRO with global reach, flexibility to execute a complex FIH trial, deep expertise in ADC safety and operational challenges and a proven track record designing and delivering Project Optimus-compliant trials.
The challenge
The biotech engaged Catalyst Oncology to design and deliver a large, global FIH study of a novel ADC therapy for NSCLC. Facing compressed timelines, the sponsor needed to evolve the study from a traditional 3+3 all comers solid tumor dose escalation into a global, dose escalation and expansion trial aligned with Project Optimus principles.
Adding to the urgency, the competitive landscape was shifting rapidly, with other biopharma companies accelerating development timelines for similar therapies—raising the stakes for securing first-to-market position.
The solution
Catalyst rapidly mobilized our regulatory, medical, and statistical experts to revise the study protocol, replacing the 3+3 design with a backfilling Bayesian optimal interval design (BF-BOIN) model. This enabled global enrollment of over 250 patients and accelerated timelines by enrolling NSCLC patients from the outset, bypassing traditional escalation across multiple solid tumor indications.
To avoid delays and competing protocols, Catalyst expanded early beyond the US, activating 55 sites across seven countries in Europe and Asia-Pacific. This enabled the US team to remain focused on dose escalation and cohort management.
A seamless protocol with multiple expansion arms and go/no-go inflection points supported rapid progression to registrational studies and fundraising. Catalyst applied flexible commercial terms to support sponsor cash flow and align project and corporate goals. A robust governance framework enabled agile problem-solving and direct executive alignment, reinforced by quarterly meetings, shared KPIs and milestone celebrations—solidifying Catalyst and the sponsor as true development partners.
The outcome
With dose escalation successfully completed, the study is enrolling ahead of schedule in the expansion phase, supported by early safety and efficacy signals and data presented at key industry events. Backed by FDA Fast Track designation, the sponsor is evaluating a transition to a registration trial. They are extremely pleased with Catalyst’s proactive approach, responsiveness, and ability to deliver a global FIH ADC trial that has put them on track to bring a best-in-class ADC therapy to NSCLC patients.
