Clinical

ARC-166 PET agent guides first ARC-706 patient dose

Archeus has started a phase I study pairing the Y-86 ARC-166 diagnostic agent with Y-90 ARC-706 therapy in metastatic cancer patients receiving immune checkpoint inhibitors.

Archeus Technologies has dosed the first patient in a phase I study of ARC-706 and its companion diagnostic ARC-166 in metastatic cancer patients receiving immune checkpoint inhibition therapies. The first-in-human study is being conducted at the University of Wisconsin Carbone Cancer Center, according to the company.

The trial pairs Y-86 ARC-166 PET imaging with Y-90 ARC-706 radiopharmaceutical therapy. Participants receive intravenous ARC-166 first for dosimetry and patient selection before receiving ARC-706, Archeus said.

Study endpoints include safety, biodistribution, pharmacokinetics, and the potential for ARC-706 to augment anti-tumor immune response. The trial is also designed to determine an optimal phase Ib dose and explore changes in cancer-related biomarkers.

ARC-706 uses Archeus’ NM600 tumor-targeting platform with the beta-emitting isotope yttrium-90. ARC-166 uses the PET isotope yttrium-86 as the imaging component of the theranostic pair.

Archeus is developing the therapy for combination use with validated immunotherapies across multiple oncology indications. The study is enrolling patients with metastatic cancer who are receiving immune checkpoint inhibitors, according to the University of Wisconsin School of Medicine and Public Health.

Preclinical studies showed tumor-selective uptake of ARC-706 in multiple cancers treated with immune checkpoint inhibitors, according to the company. Archeus also said imaging-guided dosing based on ARC-166 results increased response rates and response durability in preclinical work.

The company previously said ARC-706 and ARC-166 received FDA investigational new drug clearances in October 2024. In a June 2025 release, Archeus said it planned to advance the 2 assets together as a theranostic pair into clinical development.

UW said Archeus has ties to the University of Wisconsin-Madison, UW Health’s Isthmus Project, and the Wisconsin Alumni Research Foundation. The company has described the University of Wisconsin collaboration as supporting radiochemistry, imaging, dosimetry, and analytical work.

The current trial remains an early-phase study. Archeus said the treatment and imaging approach is being evaluated in patients continuing immunotherapy despite signs of disease progression.

radiopharmaceutical therapytheranosticsPET imagingyttrium-90,immune checkpoint inhibitors
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