Archeus Technologies Initiates First-in-Human Trial of ART-101 PSMA-Targeting Radioligand Therapy for Metastatic Prostate Cancer
核心洞察
Archeus Technologies (搜索) has dosed the first patient in a Phase 1 clinical trial of ART-101, a novel PSMA (搜索)-targeting radioligand therapy for metastatic castration-resistant prostate cancer (搜索).
Preclinical studies demonstrated that ART-101 exhibits higher tumor uptake and retention while showing lower normal tissue and salivary gland uptake compared to current FDA-approved PSMA (搜索)-targeting agents.
The Phase 1 study will enroll approximately 10 mCRPC patients to evaluate safety, biodistribution, and tumor targeting using SPECT/CT imaging with [111In]In-ART-101 (搜索).
Archeus Technologies (搜索) has achieved a significant milestone in prostate cancer (搜索) treatment development by dosing the first patient in its Phase 1 clinical trial of ART-101, a novel receptor-based targeting small molecule designed for imaging and treatment of metastatic castration-resistant prostate cancer (搜索) (mCRPC). The therapy represents a potential advancement in PSMA (搜索)-targeting radioligand therapies, with preclinical data suggesting improved therapeutic characteristics compared to currently approved agents.
Novel PSMA-Targeting Approach Shows Promise
ART-101 was invented and developed by Reinier Hernandez, Ph.D., assistant professor of medical physics at the University of Wisconsin School of Medicine and Public Health and chief technology officer of Archeus Technologies (搜索), with substantial development support from the Wisconsin Alumni Research Foundation (搜索) (WARF). The therapy targets prostate-specific membrane antigen (搜索) (PSMA (搜索)), similar to several FDA-approved imaging and therapeutic agents currently in clinical use.
In preclinical studies, ART-101 demonstrated superior characteristics compared to existing PSMA (搜索)-targeting agents. The experimental therapy exhibited higher tumor uptake and retention, as well as lower normal tissue and salivary gland uptake, relative to current FDA-approved PSMA-targeting agents. These findings suggest potential for improved therapeutic efficacy while reducing side effects commonly associated with radioligand therapies.
Phase 1 Trial Design and Objectives
The first-in-human imaging study is being conducted in mCRPC patients who are candidates to receive radioligand therapy with FDA-approved prostate cancer (搜索) treatment Pluvicto® (177Lu-PSMA-617). The Phase 1 study will assess the safety, feasibility, biodistribution and kinetics, and tumor targeting of SPECT/CT imaging with [111In]In-ART-101 (搜索).
Investigators plan to enroll approximately 10 patients with mCRPC in the trial. Participants will receive intravenous ART-101 radiolabeled with the diagnostic isotope Indium-111 to evaluate its safety profile and targeting characteristics. Each patient will undergo 8 SPECT/CT scans—4 after administration of [111In]In-ART-101 (搜索) and 4 after administration of [177Lu]Lu-PSMA-617—with follow-up continuing for approximately 2 months.
Patients are excluded from enrollment if they are undergoing other concurrent cytotoxic chemotherapy, immunotherapy, radiopharmaceutical therapy, or investigational therapy, ensuring the study can accurately assess ART-101's specific effects.
Addressing Current Treatment Limitations
"While current radioligand therapies provide a meaningful therapeutic benefit to patients with advanced prostate cancer (搜索), there are opportunities to even further enhance a patient's quality of life and reduce even minimal side effects," said Harshad Kulkarni, M.D., chief medical advisor at BAMF Health and principal investigator of the study. "This is especially important with upcoming alpha emitter-based therapies, where lower salivary gland uptake may help mitigate xerostomia (搜索)."
The potential for reduced salivary gland uptake represents a significant clinical advantage, as xerostomia (搜索) (dry mouth) is a notable side effect of current PSMA (搜索)-targeting radioligand therapies that can significantly impact patient quality of life.
Strategic Collaboration and Development Platform
Through a collaboration agreement with WARF, the designated patent and licensing organization for the University of Wisconsin–Madison, Archeus is leading the clinical development of ART-101. BAMF Health, serving as the clinical trial site, operates as a vertically integrated comprehensive Theranostics center designed to facilitate next-generation theranostic agents.
"As a vertically integrated comprehensive Theranostics center, BAMF Health was built to facilitate the next generation of theranostic agents," Kulkarni noted. "Our nationwide platform allows us to rapidly initiate and complete novel clinical trials like this, accelerating access to innovative options for patients."
Hernandez emphasized the broader implications of the trial for Archeus Technologies (搜索)' development approach: "This clinical trial reflects Archeus' foundational belief that precision imaging and dosimetry are essential to realizing the full potential of radiopharmaceutical therapy, as well as our commitment to advancing the broader portfolio and platform we are building."