Designing Early-Phase Radioligand Therapy Trials: What Makes Them Different?

Aman Chauhan, MD, Sylvester Comprehensive Cancer Center, Miami, Florida, discusses the key differences between conventional phase I oncology trials and early-phase radioligand (theranostic) therapy trials. 

In the video, he explains that unlike traditional drug development, radiopharmaceutical studies must incorporate radiobiology, quantitative imaging, and dosimetry to determine maximum safe absorbed radiation doses, account for cumulative toxicity, and guide adaptive treatment decisions. He also highlights the unique biomarker role of companion diagnostic imaging, distinct safety considerations, and the added regulatory and operational complexities involved in developing theranostic agents.

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