Cellectar Biosciences has filed an application with the U.S. Food and Drug Administration (FDA) to advance CLR 131 into a proposed Phase 1 clinical trial testing the investigational drug in children and teenagers with rare and orphan cancers.
CLR 131 is an investigational phospholipid drug conjugate (PDC), a cancer therapy that explores the tumor-targeting properties of phospholipid molecules to selectively deliver radiation to malignant tumor cells.
CLR 131 uses the PDC tumor-targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131, directly to tumor cells. This mechanism of action was developed to minimize radiation exposure to normal tissues.
The proposed Phase 1 clinical study will evaluate the safety and tolerability of a single intravenous (IV) administration of CLR 131 in up to 30 pediatric cancer patients. Eligible diagnoses include neuroblastoma, sarcomas, lymphomas — including Hodgkin’s lymphoma — and malignant brain tumors.
One secondary objective of the proposed study is to identify the recommended Phase 2 dose of CLR 131. Another objective is to determine treatment response of the investigational treatment in the children and teens enrolled in the trial.
The study will be conducted by researchers at the University of Wisconsin Carbone Cancer Center who have been involved in demonstrating the uptake of CLR 131 and other PDCs. “Together, our hope is to bring new and effective treatment options for children battling life-threatening cancers,” John Friend, MD, chief medical officer of Cellectar, said in a press release.
“We are particularly pleased to advance CLR 131 in this refractory pediatric patient population as currently most of these children have a very poor prognosis for survival. We are highly encouraged by the preclinical data in pediatric cancers that have shown CLR 131 to have meaningful benefit on tumor growth rates and survival,” said Jim Caruso, president and chief executive officer of Cellectar.
CLR 131 has already been granted orphan drug status by the FDA for the treatment of multiple myeloma. The drug is currently being tested in a Phase 1 clinical study in patients with relapsed or refractory myeloma.
In 2016, Cellectar released the study design of a Phase 2 trial (NCT02952508), which is now assessing CLR 131’s efficacy in adults with a range of B-cell malignancies.
The Phase 2 study is currently recruiting patients with relapsed or refractory B-cell hematologic cancers in several cancer centers in the United States. Eligible diagnoses include myeloma, chronic lymphocytic leukemia/small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, mantle cell lymphoma, and potentially diffuse large B-cell lymphoma.
The study’s primary objectives are measurements of clinical benefit response. Secondary measures include progression-free survival, median overall survival, and other markers of efficacy. For more information, please visit the clinical trial’s Contacts and Locations page.
