Festival of Biologics
13 October 2026
13.30 h | Theatre 10
Showcase
First in Human Dose Selection for ADCs and TCEs Using PK/PD and QSP
First-in-human dose selection remains one of the highest-stakes decisions in oncology drug development—particularly for complex modalities such as Antibody-Drug Conjugates (ADCs) and T-cell Engagers (TCEs). Misjudging this step can lead to delayed development, unnecessary patient risk, and significant value loss.
In this workshop, LYO-X presents an integrated, model-informed strategy to de-risk and accelerate FIH dose prediction. For ADCs, the focus is on translating preclinical data into a robust understanding of therapeutic dose and window. For TCEs, the challenge lies in identifying a starting dose that is both safe and sufficiently close to pharmacological activity, minimizing dose-escalation steps and avoiding subtherapeutic exposure.
By combining in vitro and in vivo preclinical data with advanced PK/PD and quantitative systems pharmacology (QSP) modelling, LYO-X demonstrates how to generate data-driven, decision-ready dose recommendations. The session will highlight how this approach enables more confident clinical entry, optimizes trial design, and ultimately accelerates time to proof-of-concept.
