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Phase 0 Radiopharmaceutical–Agent Clinical Development
oleh: Charles A. Kunos, Larry V. Rubinstein, Jacek Capala, Michael A. McDonald
Format: | Article |
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Diterbitkan: | Frontiers Media S.A. 2020-08-01 |
Deskripsi
The evaluation of antibody-targeted or peptide-targeted radiopharmaceuticals as monotherapy or in oncological drug combinations requires programmatic collaboration within the National Cancer Institute (NCI) clinical trial enterprise. Phase 0 trials provide a flexible research platform for the study of radiopharmaceutical–drug pharmacokinetics, radiation dosimetry, biomarkers of DNA damage response modulation, and pharmacodynamic benchmarks predictive of therapeutic success. In this article, we discuss a phase 0 clinical development approach for human antibody-targeted or peptide-targeted radiopharmaceutical–agent combinations. We expect that early-phase radiopharmaceutical–agent combination trials will become a more tactical and more prevalent part of radiopharmaceutical clinical development in the near-term future for the NCI Cancer Therapy Evaluation Program.