Cellectar completes enrollment in (131)I-CLR1404 Phase I dosimetry trial for advanced solid malignancies

Cellectar, Inc., a privately held radiopharmaceutical company that designs and develops products to detect, treat and monitor human cancers, today announced that enrollment for its Phase I dosimetry trial for its lead drug candidate, (131)I-CLR1404 has been completed. Results of this trial will be used to set the starting dose in a follow-on Phase I dose escalation study planned for later this year. Institutions that participated in the trial include City of Hope, Duke University Medical Center, Georgetown University/Lombardi Cancer Center, and Johns Hopkins Hospital.  

Eight patients with advanced solid malignancies were enrolled in the trial which was designed to measure drug safety and the normal organ and whole body dosimetry of (131)I-CLR1404. Dosimetry measurements allow investigators to understand how the radiopharmaceutical will impact non-tumor organs and how it clears from the body over time. Results will be used to set the starting dose for the second Phase I study – a dose escalation study to determine the Maximum Tolerated Dose (MTD) of (131)I-CLR1404 in patients with advanced solid malignancies.

Lead investigator Joanne Mortimer, MD, Vice Chair of Medical Oncology & Therapeutics Research, City of Hope, said, "This drug candidate has the potential to treat many tumor types, including some of the most challenging. The results of this initial study will provide a better understanding of the full potential of (131)I-CLR1404 and, enable us to move forward toward determining an appropriate therapeutic dose for patients."

Cellectar's President and CEO, Bill Clarke, M.D., commented, "The dosimetry and biodistribution results of this study reveal both the initial safety profile of this drug and an approximate possible dose range that a patient could receive in a therapeutic situation. We look forward to continuing the development of (131)I-CLR1404 in order to determine the safe dose, and then to begin our efficacy studies. Having the opportunity to assess the potential of (131)I-CLR1404 therapy for solid tumor patients who have few treatment options is our primary goal."

SOURCE Cellectar, Inc.