Cellectar Biosciences Provides Update on CLOVER-2 Phase 1 Clinical Trial of Iopofosine I 131 in Pediatric Patients with Relapsed/Refractory High-Grade Glioma

Core Insights - Cellectar Biosciences, Inc. announced promising initial results from the CLOVER-2 Phase 1 clinical trial of iopofosine I 131 for treating relapsed/refractory pediatric high-grade glioma (pHGG) patients, showing an average progression-free survival (PFS) of 5.4 months, which is more than double the previously reported median of 2.25 months [1][2][4] Group 1: Clinical Trial Results - The CLOVER-2 trial involved 14 patients diagnosed with various forms of pHGG, including diffuse midline gliomas and anaplastic ependymomas, with poor historical outcomes of approximately 2.25 months for median PFS and 5.6 months for overall survival (OS) [2] - Patients receiving a minimum of 55 mCi total administered dose experienced an average PFS of 5.4 months and an OS of 8.6 months, with all patients achieving disease control [3] - Three patients who received additional dosing cycles had an average PFS of 8.1 months and an OS of 11.5 months, with two achieving an objective response rate [3] Group 2: Safety and Tolerability - Iopofosine I 131 was well tolerated, with a safety profile consistent with previous data, showing no significant cardiovascular, renal, or liver toxicities, and manageable hematologic adverse events [4] - The most common treatment-emergent adverse events were hematologic, including thrombocytopenia, neutropenia, and anemia, all of which were predictable and manageable [4] Group 3: Trial Design and Objectives - The ongoing Phase 1b trial is designed to evaluate the safety and tolerability of iopofosine I 131 in children, adolescents, and young adults with relapsed/refractory high-grade glioma, with two dosing cohorts planned [5] - The study aims to determine therapeutic activity defined by PFS and OS, as well as antitumor activity through tumor volume reduction, and to identify the recommended Phase 2/3 dose [5] Group 4: Company Overview - Cellectar Biosciences focuses on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate™ (PDC) delivery platform to enhance efficacy and safety [6] - The company's pipeline includes iopofosine I 131 and other programs targeting various solid tumors, with iopofosine I 131 also studied in Phase 2b trials for multiple myeloma and CNS lymphoma [7][9]