Phase I ADC Breast Cancer Case Study

A First-in-human, Phase I/II Study of an Antibody-Drug Conjugate in Patients with Advanced Solid Tumors

 

Challenges with mitigations

Multiple physicians supporting this trial have led to differences in opinion. Cmed established clear communications 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 Cmed team was able to support and resolve this quickly

Cmed project manager turnover (n=1) addressed with Senior oversight by stepping in to the project to apply their historical knowledge of the project to ease the transition burden on site and sponsor teams

Real-time enrollment insight(s) support cohort management
Real-time enrollment insight(s) support cohort management
Real time, customizable insights of results over time facilitate ongoing safety oversight
Real time, customizable insights of results over time facilitate ongoing safety oversight

Successes

  • 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

Trial Summary    
Disease/indication Solid tumor (breast cancer)
Type of study Phase I
Product Intravenous administration
Sites USA & Europe
Project timeline 2019 - Present
Trial design Accelerated-titration design followed by the standard "3+3" design
Escalation: solid tumor
Expansion: two pre-specified cohorts (Triple Negative Breast Cancer and not TNBC)