Planning a Route Forward
Planning a First in Human (FiH) study
CellCentric approached Aptus Clinical to assist them in designing their First in Human (FiH) study for their lead project, a small molecule inhibitor of p300/CBP
Aptus Clinical convened a multi-disciplinary panel of medical, scientific and technical experts to ensure CellCentric received industry-leading input into the development of an innovative clinical plan to support the development of their lead oncology asset
A comprehensive clinical plan for a FiH study was produced. This included:
- Study Design Concept, including endpoints, patient population/numbers, outcome variables and statistical considerations
- Go/no-go triggers for starting additional modules
- Phase II study options, including combination strategies and additional patient segments
- High level time and study budget estimates
- Competitor landscape reports for mode of action and tumour types of interest
CellCentric was delighted with how the Aptus Clinical team partnered seamlessly with their small in-house team to produce a plan that provided the insights they needed to confidently enter discussions with their key stakeholders and investors
A fabulous job – many thanks all. A clear basis around which to plan our transition from discovery to development.