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From clinical development plan via healthy volunteer study to phase I study

From clinical development plan via healthy volunteer study to phase I study

A stock exchange listed biotech company with a first-in-human, first-in-class, targeted agent initially asked SMS-oncology to prepare a clinical development plan that should specifically address the choice for target profile and positioning, target indications and tumor type(s), drug combination(s) and trial design.

SMS-oncology prepared a de-risked clinical development plan including a clinical trial strategy to obtain Proof of Concept. SMS-oncology’s main recommendation was to consider performing a healthy volunteer study before entering specific patient populations as this step would save time and money, as well as provide the safety/tolerability and pharmacokinetic data required to continue clinical development. The clinical development plan and the recommendations were endorsed by two leading cancer experts.

Due to the close collaboration throughout the strategic planning and healthy volunteer study, upon successful completion of the latter, SMS-oncology seamlessly executed a continuous infusion, “3+3 design” dose escalating Phase Ib study in patients with solid tumors at two European cancer centers.