Antibody-drug conjugates (ADCs) are transforming cancer care by combining precision antibody targeting with potent payloads to improve patient outcomes. For biotech Sponsors, early-phase development is critical—where challenges are greatest and decisions shape the path forward.
Catalyst Oncology is a specialty CRO dedicated to guiding biotechs through early development into late-stage success. With 20+ years of experience supporting small- to mid-sized sponsors, Catalyst offers scientific depth, operational agility, and a people-first approach. Our flexible, data-driven infrastructure enables real-time trial monitoring, while strong PI/KOL relationships and advanced technology ensure efficient, high-quality execution.
Navigating the Complexities of Early Phase ADC Trials
ADC development is especially demanding in First-in-Human (FIH) and early phase clinical trials. Sponsors must balance scientific ambition with operational feasibility, all while navigating a crowded and competitive landscape. Common challenges include:
Project Optimus protocol design and speed to proof of concept
Sponsors must design protocols that address evolving FDA expectations around dose escalation, optimization and expansion while maintaining speed and flexibility.
Global feasibility & site selection
With over 1,100 ADCs in development globally, competition for sites and patients is fierce. Sponsors must stand out with novel ADC technology, compelling protocols and streamlined operations.
Safety & toxicity management
ADCs often present unique toxicity profiles—ocular, neurologic, pulmonary, and hematologic—that require vigilant monitoring and adaptive dosing strategies.
Biomarker-driven recruitment and CDx developmen
Identifying the right patients through validated assays and eligibility criteria is critical, as is balancing timelines and when to deploy a companion diagnostic strategy.
Positioned for Phase III Success
With early phase development complete and an optimized ADC dose established for the target patient population, the focus shifts to market access. Catalyst ensures your program is built on a foundation for long-term success and can help bring your drug through registration and to patients in need by navigating common challenges like:
- Competitive landscape and access to KOLs
In a highly competitive landscape, speed matters. Catalyst leverages its global presence and robust KOL connections to accelerate enrollment, helping Sponsors advance their path to market. - Quality oversight and accelerated approvals
Regulatory and quality strategies including accelerated paths, confirmatory trials and payer access are critical to plan early. Inspection steadiness is key from the outset.
Proven ADC Trial Expertise
Catalyst Oncology’s ADC portfolio spans solid tumors and hematologic malignancies, advancing therapies through:
Numerous active ADC trials including FIH trials with rapid FPI goals
Global footprint with 1,000+ staff spanning North America, Europe and Asia-Pacific
Operational scale with ADC study experience across >120 sites and PIs
Next generation technologies with specialized expertise working with novel antigens, linkers and payloads (e.g. topo1 inhibitors, MMAE, PBDs, etc.)
Let’s Talk
Whether you’re designing your first ADC study, optimizing an early phase program, or preparing for a global registrational trial, Catalyst Oncology is ready to help. Connect with us to learn how we can accelerate your development and overcome the toughest challenges in ADC drug development.
