Planning a Route Forward

Planning a First in Human (FiH) study

The Challenge

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

The Solution

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

The Outcome

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
The Feedback

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.

Will West

CEO, CellCentric

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