The trial of investigational therapy ARC-706 and companion diagnostic agent ARC-166 is part of the company’s effort to advance a portfolio of differentiated small-molecule radiopharmaceutical therapies to address some of the most difficult-to-treat cancers.
The study is enrolling patients with metastatic cancer who are receiving immune checkpoint inhibition (ICI) therapies.
Archeus is developing ARC-706 for combination use with certain validated immunotherapies across various types of cancer treatments. ARC-706 uses Archeus’ NM600 tumor-targeting platform with the addition of the therapeutic beta-emitting isotope yttrium-90 (Y-90), as well as the PET isotope yttrium-86 (Y-86) comprising ARC-166.
In this first-in-human imaging and therapy study, participants will receive intravenous ARC-166 for dosimetry and patient selection, followed by ARC-706 to evaluate its safety, biodistribution, pharmacokinetics, and potential to augment anti-tumor immune response. The study also aims to determine an optimal Phase 1b dose of ARC-706 and explore changes in relevant cancer-related biomarkers.
“This study allows us to evaluate a new therapeutic strategy designed to support patients who are continuing immunotherapy despite signs of disease progression,” said Dr. Grace Blitzer, assistant professor of human oncology at the University of Wisconsin School of Medicine and Public Health, radiation oncologist at the UW Carbone Cancer Center, and a principal investigator of the study. “By combining functional imaging with targeted radiotherapy, we hope to demonstrate meaningful clinical benefit to patients without disrupting ongoing immune-based treatment—a goal that could have wide-reaching impact across multiple tumor types.”
Preclinical studies have demonstrated tumor-selective uptake of ARC-706 in multiple cancers that are treated with ICI therapies, and that administering ARC-706 at specific dose ranges based on ARC-166 imaging results can significantly increase the response rate to ICI therapies and the durability of responses.
“By using imaging to guide therapy and selectively deliver radiation to tumors, this trial is designed to optimize treatment selection and potentially improve responses to immune checkpoint inhibitors in patients who currently face limited options,” said Dr. Zachary Morris, associate professor and chair of the Department of Human Oncology. Morris also serves as chief medical officer of Archeus Technologies and co-chair of the study. “It also reflects our broader goal of advancing radiopharmaceutical strategies that can be applied across a range of difficult-to-treat cancers.”
