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Phase I Endpoints — SCE Medical Oncology MCQ

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HardClinical Trials & StatisticsPhase I EndpointsSCE Medical Oncology

In a first-in-human trial, receptor occupancy and downstream pharmacodynamic effect plateau at 80 mg, while dose-limiting toxicity emerges above 160 mg and chronic grade 2 toxicity increases with exposure. Which dose concept should primarily guide expansion-cohort selection?

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Correct answer: C — An optimal biological dose balancing exposure target effect and tolerability

Expansion should use an optimal biological dose integrating exposure, target engagement, early activity and both acute and chronic tolerability. A maximum tolerated dose integrating dose-limiting toxicity and acute tolerability: MTD alone overlooks the lower exposure at which target engagement plateaus and chronic toxicity rises. A minimum active dose integrating a single response and acute tolerability: one response does not define a robust expansion dose. A recommended phase-two dose integrating acute toxicity and dose intensity: the label is plausible, but the decision principle described is specifically optimal biological dosing. A pharmacokinetic-equivalent dose integrating exposure and body-surface area: PK equivalence does not integrate pharmacodynamics, activity and tolerability.

Reference: Improving dose-optimization processes in oncology drug development (Published September 2022): https://pubmed.ncbi.nlm.nih.gov/36095296/; GMC good practice in research and consent (Effective April 2024): https://www.gmc-uk.org/professional-standards/the-professional-standards/good-practice-in-research-and-consent/good-practice-in-research