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Updated: Dec 6, 2025

Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules
Published on: October 4, 2024
Phase 0 Radiopharmaceutical-Agent Clinical Development
Charles A Kunos1, Larry V Rubinstein1, Jacek Capala2
1Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, United States.
Abstract:
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.
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