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Three steps toward dose optimization for oncology dose finding.

Jason J Z Liao1, Ekaterine Asatiani2, Qingyang Liu1

  • 1Incyte Corporation, 1801 Augustine Cut-off, Wilmington, DE, 19803, United States.

Contemporary Clinical Trials Communications
|July 22, 2024
PubMed
Summary
This summary is machine-generated.

A new three-step method enhances oncology drug dose selection beyond traditional maximum tolerated dose (MTD) approaches. This strategy optimizes doses for registration trials, balancing safety and efficacy for targeted therapies.

Keywords:
Dose findingDose optimizationFractional factorial designHybrid designMTD/MADRDE

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Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Drug Development

Background:

  • Traditional oncology dose selection relies on maximum tolerated dose (MTD), which may be unsuitable for molecularly targeted therapies due to differing toxicity profiles.
  • The US Food and Drug Administration's Project Optimus aims to reform dose optimization in oncology drug development.

Purpose of the Study:

  • To propose and detail a "three steps toward dose optimization" procedure in response to Project Optimus initiatives.
  • To enhance the selection of optimal doses for oncology registration trials.

Main Methods:

  • Step 1: Dose escalation using an efficient hybrid design to identify the MTD or maximum administered dose with overdose control.
  • Step 2: Selection of recommended doses for expansion (RDEs) based on safety, pharmacokinetic, pharmacodynamic, and biomarker data.
  • Step 3: Dose optimization using a randomized fractional factorial design with multiple RDEs across tumor cohorts.

Main Results:

  • The proposed hybrid design improves MTD identification accuracy.
  • Integration of diverse data (safety, PK, PD, biomarkers) informs RDE selection.
  • Fractional factorial designs allow exploration of multiple doses and tumor types for optimal registration dose selection.

Conclusions:

  • The three-step approach increases the likelihood of selecting an optimal dose for registration trials.
  • This method aims to achieve a balanced safety profile while preserving efficacy.
  • It facilitates the identification of tumor types most responsive to the investigational treatment.