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Takeaways:
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The first three patients in the world have been treated in a Phase 1 clinical trial of RYZ401.
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RYZ401 is a novel radiopharmaceutical that specifically targets somatostatin receptors on neuroendocrine tumor (NET) cells, or “docking sites” on the surface of some cells, helping deliver radiation directly to cancer while sparing healthy tissue.
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The therapy is part of a growing field combining diagnostics and treatment in one approach, called theranostics.
Impact: The trial could help expand targeted radiopharmaceutical treatments to more types of cancer.
Huntsman Cancer Institute at the University of Utah (the U) has treated the first three patients in the world in a first-in-human clinical trial of RYZ401, a next-generation targeted therapy for neuroendocrine tumors (NETs) and other solid tumors in the cutting-edge field of radiopharmaceuticals. These radioactive drugs help doctors both locate tumors and deliver a targeted radiation dose directly to cancer cells while sparing healthy tissue.
The Phase 1 clinical trial, sponsored by RazyeBio, Inc., a Bristol Myers Squibb Company, is led by Heloisa Soares, MD, PhD, medical director of the Clinical Trials Office and medical director of theranostics at Huntsman Cancer Institute and associate professor of internal medicine at the U.
“This study represents an important step toward developing the next generation of targeted radiopharmaceutical therapies,” says Soares. “We are proud that Huntsman Cancer Institute was able to treat the first patients in this international trial and help advance new treatment options for people living with NETs and other cancers.”
NETs are rare and often slow-growing cancers that develop in neuroendocrine cells, which release and regulate hormones. This type of tumor is often characterized by having a high density of somatostatin receptors on the surface of the cell. Somatostatin is a hormone that stops the release of other hormones.
“This study represents an important step toward developing the next generation of targeted radiopharmaceutical therapies.”
Heloisa Soares, MD, PhD
RYZ401 is an investigational radiopharmaceutical designed to target these somatostatin receptors and slow tumor growth. Diagnostic radiopharmaceuticals work by first finding cancer cells with a radioisotope that makes tumors visible in a somatostatin receptor imaging PET-CT scan. Once those cells are identified, patients receive an infusion with a more powerful version of the radiopharmaceutical that uses a therapeutic radioisotope to destroy the cancer cells.
RYZ401 combines a novel peptide, or string of amino acids, with the therapeutic radioisotope Actinium-225, which emits alpha particles, delivering a powerful dose of energy over a very short distance. Radiopharmaceuticals like RYZ401 are used in an emerging form of cancer treatment known as theranostics, which combines therapeutics and diagnostics. Huntsman Cancer Institute is a national leader in theranostics and has additional clinical trials open or in the process of being available for brain, breast, prostate, lung, neuroendocrine, and pancreatic cancers.
“These therapies require sophisticated infrastructure and close collaboration between imaging scientists, physicists, physicians, and clinical trial teams.”
Jeffrey Yap, PhD
“Clinical trials using radiopharmaceutical therapies require sophisticated infrastructure and close collaboration between imaging scientists, physicists, physicians, and clinical trial teams,” says Jeffrey Yap, PhD, research director of theranostics at Huntsman Cancer Institute and professor of radiology and imaging sciences at the U. “What makes Huntsman Cancer Institute unique is our ability to bring all of these elements together in one place—combining cutting-edge imaging, specialized expertise, and a deeply collaborative environment.”
The Phase 1 first-in-human (NCT07165132) clinical trial evaluates RYZ401’s safety, tolerability, and early signs of effectiveness. The study is currently enrolling patients with advanced NETs or other cancers that express somatostatin receptors.
The critical research happening every day at Huntsman Cancer Institute is supported by the National Institutes of Health/National Cancer Institute, including cancer center support grant P30 CA042014, as well as Huntsman Cancer Foundation.
Media Contact
Heather Simonsen
Public Affairs Senior Manager
Huntsman Cancer Institute
801 581-3194
public.affairs@hci.utah.edu
About Huntsman Cancer Institute at the University of Utah
Huntsman Cancer Institute at the University of Utah is the National Cancer Institute-designated Comprehensive Cancer Center for Utah, Idaho, Montana, Nevada, and Wyoming. With a legacy of innovative cancer research, groundbreaking discoveries, and world-class patient care, we are transforming the way cancer is understood, prevented, diagnosed, treated, and survived. Huntsman Cancer Institute focuses on delivering the most advanced cancer healing and prevention through scientific breakthroughs and cutting-edge technology to create pioneering cancer treatments beyond the standard of care today. We have more than 400 open clinical trials and more than 300 research teams studying cancer. More genes for inherited cancers have been discovered at Huntsman Cancer Institute than at any other cancer center. Our scientists are world-renowned for understanding how cancer begins and using that knowledge to develop innovative approaches to treat each patient’s unique disease. Huntsman Cancer Institute was founded by Jon M. and Karen Huntsman.