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Adaptation of Semiautomated Circulating Tumor Cell CTC Assays for Clinical and Preclinical Research Applications
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Adaptation of Semiautomated Circulating Tumor Cell CTC Assays for Clinical and Preclinical Research Applications

Published on: February 28, 2014

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A perspective review on the systematic implementation of ctDNA in phase I clinical trial drug development

Nolwen Guigal-Stephan1, Brian Lockhart2, Tina Moser3

  • 1Translational Medicine, Institut de Recherches Servier, 22 route 128, Gif-sur-Yvette, Saclay, 91190, France. nolwen.guigal-stephan@servier.com.

Journal of Experimental & Clinical Cancer Research : CR
|February 28, 2025
PubMed

Insights

Circulating tumor DNA (ctDNA) shows promise for early cancer trials. Integrating ctDNA testing in Phase I studies can improve patient selection, dosing, and drug efficacy assessment.

Area of Science:

  • Oncology
  • Genomics
  • Biomarker Discovery

Background:

  • Circulating tumor DNA (ctDNA) is a vital biomarker in advanced cancer care.
  • ctDNA-based genomic profiling and companion diagnostics are established in clinical practice.
  • The use of ctDNA in early-phase (Phase I) oncology drug development is currently limited.

Purpose of the Study:

  • To explore the potential of ctDNA testing in Phase I clinical trials.
  • To identify challenges and opportunities for ctDNA application in early drug development.
  • To support informed decision-making for patient inclusion, dose optimization, and proof-of-mechanism.

Main Methods:

  • Review of current ctDNA applications and potential in early-phase trials.
  • Discussion of cost-efficient, genome-wide techniques like low-pass whole genome sequencing and fragmentomics.
  • Consideration of methylation-based methods for ctDNA analysis.

Main Results:

  • ctDNA analysis offers significant opportunities for optimizing Phase I trials.
  • Systematic integration of ctDNA can enhance patient selection and monitoring.
  • Cost-effective genomic techniques can facilitate broader ctDNA adoption in early trials.

Conclusions:

  • ctDNA testing holds substantial potential for revolutionizing early-phase oncology drug development.
  • Overcoming current hurdles will enable more efficient and informative Phase I trials.
  • Integrating ctDNA analysis supports personalized medicine and accelerates the development of novel cancer therapies.
Keywords:
Circulating tumour DNA (ctDNA)Molecular responsePharmacodynamicsPharmacokineticsPhase I trialRECISTTumour fraction

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