Early-Phase Oncology: First-In-Human Study in Advanced Solid Tumors

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 by your side, helping to differentiate your trial from all others.

Phase 1, First In Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of [IP] in Patients with Advanced Solid Tumors

Trial Design:

3+3 escalation to expansion
Escalation: solid tumor
Expansion: muscle invasive bladder cancer

Product: Intravenous or subcutaneous administration, synthetic antifungal
Sites: 4 escalation, 7 expansion
Services: site management, project management monitoring, safety, medical monitoring, data and analytics, medical writing
Dates: 2017 to present

Successes

Rapid site activation using proven study start up processes
Enrollment ahead of schedule in escalation due to proactive cohort management, engaged investigators and minimal time between DLT close and Safety Review Committee meetings
Minimal time (>3 days) to dose escalation review and decisions via use of encapsia expoerts and insights allowing dose decisions to happen faster
Information and data visibility from encapsia allowed Aixial management to seamlessly step into project work and each project transition burden on-site and Sponsor teams

Challenges with Mitigations

Slower than expected enrollment in expansion resolved by opening an additional site within the escalation site network.
IP capping issue resolved by efficient collection and replacement of onsite IP material
Team turnover addressed by Senior and Executive oversight.
A younger client with limited budget mitigated by cross-functional client discussions looking at task and cost impact (positive and negative) of each protocol change being considered.

Figure 1: Study Enrollment. A stacked area chart tracking the number of subjects enrolled during the study