Early Phase Oncology: First-In-Human Study Of An Antibody-Drug Conjugate In Breast Cancer
For a First In Human study, site activation and enrollment can present challenges, but when you add in investigator differences in opinions and team turnover, things can quickly get chaotic.
This case study will show you efficiencies and advanced benefits gained by having the expert and proactive full-service team at Aixial Group by your side, helping to differentiate your trial from all others.
Phase I ADC Breast Cancer Case Study
- Accelerated-titration design followed by the standard “3+3” design
- Escalation: solid tumor
- Expansion: two pre-specified cohorts (TNBC and not TNBC)
Product: Intravenous administration
Sites: 3 escalation (USA), (7 expansion USA & Europe)
Dates: 2019 to present
Services: Full Service
- Rapid site activation, ahead of schedule
- Enrollment ahead of schedule in escalation
- Cooperative engagement with sites during single enrollment slot availability
- Prompt dose escalation review and decisions by smart data entry support and easy data visibility using encapsia insights/patient profiles
- No DTLs and single SAE (to date) quickly handled with electronic reporting processes and advanced data visibility via encapsia
Figure 1. Real-time enrollment insight(s) support cohort management
Figure 2. Real-time, customizable results over time insights facilitate on-safety oversight
Challenges with Mitigations
- Multiple physicians supporting this trial have led to differences i opinion.
- Aixial established clear communication pathways to address and resolve differences quickly, to not impede enrollment, medical oversight, safety management, etc.
- Internal sponsor team turnover resulted in rework, but the Aixial team was able to support and resolve this quickly
- Aixial project manager turnover (n=1) addressed with senior oversight by stepping into the project to apply their historical knowledge of the project to ease the transition burden on site and sponsor teams
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