Cellectar Partners with Evestia Clinical for Phase 1b Trial of CLR 125 Radiopharmaceutical in Triple-Negative Breast Cancer
核心洞察
Cellectar Biosciences has partnered with Evestia Clinical (搜索) to conduct a Phase 1b clinical trial evaluating CLR 125, an iodine-125 Auger-emitting radiopharmaceutical, for treating triple-negative breast cancer (搜索).
The trial will be conducted at a Mayo Clinic Network site with Dr. Pooja Advani as lead investigator, leveraging Evestia's expanded oncology expertise following its merger with Atlantic Research Group (搜索).
Triple-negative breast cancer (搜索) affects approximately 12% of breast cancer patients in the U.S., with about 25% experiencing relapse after standard treatments, highlighting the critical need for innovative targeted therapies.
Cellectar Biosciences has entered into a partnership with Evestia Clinical (搜索) to advance CLR 125, an innovative iodine-125 Auger-emitting radiopharmaceutical, into a Phase 1b clinical trial for triple-negative breast cancer (搜索) (TNBC (搜索)). The collaboration leverages Evestia's expanded global capabilities and oncology expertise, enhanced by its recent merger with Atlantic Research Group (搜索).
Strategic Partnership for Advanced Radiopharmaceutical Development
Under the new agreement, Evestia Clinical (搜索) will provide comprehensive contract research organization services for Cellectar's upcoming Phase 1b study. CLR 125 is designed to target solid tumors, including triple-negative breast, lung, and colorectal cancers, using Cellectar's proprietary Phospholipid Drug Conjugate delivery platform.
"ARG has been a trusted CRO partner for years and we are pleased to continue to work with the expanded team at Evestia Clinical (搜索), confident that their combined expertise and tailored approach will be instrumental in contributing to the success of this important clinical trial," said Jarrod Longcor, chief operating officer of Cellectar. "We have unwavering confidence in CLR 125, and initiation of the Phase 1b trial in TNBC (搜索) will represent a significant milestone toward bringing a new treatment option to patients."
Clinical Trial Leadership and Infrastructure
Cellectar has selected a Mayo Clinic Network site as the treatment center for the Phase 1b clinical trial, with Dr. Pooja Advani from Mayo Clinic serving as the lead investigator. This selection ensures that patients participating in the trial will be treated by highly experienced clinicians with significant domain expertise in oncology.
Paul Bishop, chief development officer of Evestia, emphasized the long-standing relationship between the organizations: "We have worked with the Cellectar team for more than a decade and look forward to continuing to support them as they move CLR 125 into clinical development as a treatment for TNBC (搜索). Following ARG's merger with Evestia Clinical (搜索), the combined Group now offers broader therapeutic expertise, an expanded US presence, and enhanced technologies that enable us to deliver truly bespoke, high-quality services to clients in complex, high-research therapeutic areas, such as oncology."
Addressing Critical Unmet Medical Need
Triple-negative breast cancer (搜索) represents one of the most challenging breast cancer subtypes to treat, characterized by the absence of estrogen receptors (搜索), progesterone receptors (搜索), and HER2 protein (搜索) expression. This lack of common therapeutic targets severely limits treatment options beyond chemotherapy. TNBC (搜索) tends to grow and spread more rapidly than other breast cancer types and disproportionately affects younger women and those of African descent.
The clinical need is substantial, with approximately 12% of breast cancer diagnoses in the U.S. being TNBC (搜索). Studies indicate that approximately 25% of TNBC cases—representing about 40,540 patients—experience relapse after standard treatments including surgery, chemotherapy, and radiation. The high recurrence rate and poor prognosis associated with TNBC create a critical need for innovative, targeted therapies to improve patient outcomes.
Cellectar's Radiopharmaceutical Pipeline
CLR 125 is part of Cellectar's broader radiopharmaceutical development program utilizing the company's Phospholipid Drug Conjugate platform. The platform is designed to deliver next-generation cancer cell-targeting treatments with improved efficacy and enhanced safety through reduced off-target effects.
Cellectar's product pipeline includes multiple radiopharmaceutical candidates: iopofosine I 131 (搜索), which has received FDA Breakthrough Therapy Designation for targeted delivery of iodine-131; CLR 121225, an actinium-225 based program targeting solid tumors with significant unmet need such as pancreatic cancer (搜索); and CLR 121125, the iodine-125 Auger-emitting program being evaluated in the upcoming TNBC (搜索) trial.
The company's lead asset, iopofosine I 131 (搜索), has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (搜索) and central nervous system lymphoma (搜索), and has received six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA for various cancer indications.