Radionetics Oncology has initiated a Phase 1 clinical trial for 68Ga-R8760, a pioneering radioligand imaging agent designed to detect adrenocortical carcinoma. The study, R8760-101 (NCT05999292), focuses on assessing the agent’s safety and dosimetry. Dr. Gary Hammer, a scientific advisor to the company, highlights the urgency of new adrenocortical carcinoma treatments, given the last FDA-approved drug dates back to 1970. Radionetics Oncology’s expertise in G-protein coupled receptors (GPCRs) has enabled rapid advancements in radiopharmaceutical agents. Their promising pipeline aims to introduce three clinical programs by 2024, addressing critical needs in cancer treatment.
Radionetics Oncology, a clinical-stage radiopharmaceutical company dedicated to advancing innovative treatments for various cancer types, is delighted to announce the commencement of its Phase 1 clinical trial for 68Ga-R8760.
Designated as Study R8760-101 (NCT05999292), this trial is designed to assess the safety and dosimetry of 68Ga-R8760, a pioneering small molecule radioligand imaging agent developed for patients diagnosed with adrenocortical carcinoma. The discovery of 68Ga-R8760 by Radionetics Oncology represents a breakthrough in identifying melanocortin 2 receptor (MC2R)-expressing adrenocortical cancer lesions, thereby enabling the selection of patients who may benefit from MC2R-targeted radioconjugate therapy. This multi-center study is being conducted in collaboration with leading experts in adrenocortical carcinoma treatment across the United States.
“Adrenocortical carcinoma is a disease that has long awaited the development of new treatment options, with the last FDA-approved drug dating back to 1970. MC2R is abundantly expressed in adrenocortical carcinoma tumors, with minimal expression in healthy tissue outside of the adrenal gland. Targeting MC2R for both diagnostics and therapeutics could revolutionize our approach to adrenocortical carcinoma,” stated Dr. Gary Hammer, M.D., Ph.D., the Millie Schembechler Professor of Adrenal Cancer at the University of Michigan Rogel Cancer Center and scientific advisor to Radionetics Oncology.
Brett Ewald, Chief Operating Officer, remarked, “Initiating this groundbreaking clinical study marks a significant milestone for Radionetics Oncology, and we achieved it in just two years since our company’s inception. Our team’s deep expertise in G-protein coupled receptors (GPCRs) has led to the discovery of novel and promising targets for oncology, like MC2R. Coupled with our company’s proficiency in chemistry, biology, and clinical development, we can rapidly advance potent and selective radiopharmaceutical agents into clinical evaluation.” Radionetics Oncology is actively developing a pipeline of new radiopharmaceuticals targeting novel cancer markers and aims to have three clinical programs underway by 2024.
About 68Ga-R8760
68Ga-R8760 is a gallium-68-labeled small molecule radioligand conjugate that exhibits a strong affinity for MC2R, a highly expressed target in adrenocortical carcinoma. It represents the first imaging agent developed to detect and localize MC2R-expressing tumors, serving as a valuable tool in identifying patients who could potentially benefit from MC2R-targeted therapeutic agents concurrently being developed by Radionetics Oncology. Adrenocortical carcinoma, a rare cancer affecting the adrenal cortex, has limited treatment options, particularly in cases of recurrence or metastasis. Despite extensive research efforts, the median survival rate for patients with metastatic disease remains under 15 months.
