Circulating tumor DNA as a biomarker in early phase clinical trials
Harold N Tan1, Mitchell J Elliott2, Ian M Silverman3
1University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Abstract:
The clinical development of novel cancer therapeutics is rapidly evolving with the integration of molecular biomarkers to advance precision medicine. Circulating tumor DNA (ctDNA) represents a versatile tool to detect targetable alterations, predict therapeutic response, monitor tumor evolution, and inform pharmacokinetic and pharmacodynamic effects. This could accelerate early phase drug development and deepen our understanding of biological drivers of response and resistance. Herein, we highlight current applications and future opportunities for ctDNA as a multi-utility biomarker in early phase clinical trials.
Insights
Circulating tumor DNA (ctDNA) is a powerful biomarker in early cancer drug development. It aids in detecting mutations, predicting treatment success, and understanding tumor changes, accelerating precision medicine.
Area of Science:
- Oncology
- Molecular Biology
- Pharmacology
Background:
- Precision medicine in cancer therapeutics relies on molecular biomarkers.
- Circulating tumor DNA (ctDNA) is emerging as a key tool in oncology.
- Early phase clinical trials are crucial for novel cancer drug development.
Purpose of the Study:
- To highlight the current applications of ctDNA in early phase clinical trials.
- To explore future opportunities for ctDNA as a multi-utility biomarker.
- To emphasize ctDNA's role in advancing precision medicine for cancer.
Main Methods:
- Literature review of ctDNA applications in early phase oncology trials.
- Analysis of ctDNA's utility in detecting targetable alterations.
- Evaluation of ctDNA's role in predicting therapeutic response and monitoring tumor evolution.
Main Results:
- ctDNA enables detection of targetable genetic alterations.
- ctDNA can predict patient response to cancer therapies.
- ctDNA provides insights into tumor evolution and resistance mechanisms.
- ctDNA informs pharmacokinetic and pharmacodynamic assessments.
Conclusions:
- ctDNA is a versatile biomarker with significant potential in early phase clinical trials.
- Integrating ctDNA analysis can accelerate the development of novel cancer therapeutics.
- Further research can expand the utility of ctDNA in precision oncology.
