Cellectar Biosciences has revealed the study design of an upcoming Phase 2 trial examining the investigational compound CLR 131 in multiple myeloma and a number of lymphoma subtypes.
The study, which will be assessing the safety and effectiveness of a single dose of CLR 131, is set to begin in the first quarter of 2017, and initial efficacy data is expected in the second half of 2017.
CLR 131, developed with Cellectar’s patented cancer cell-targeting delivery and retention platform, uses a lipid compound that delivers the cytotoxic radioisotope iodine-131 directly into tumor cells.
The drug is currently being tested in Phase 1 clinical trials in patients with multiple myeloma, and seems to improve patients’ overall response rates, progression-free survival, and quality of life. Based on these results, the U.S. Food and Drug Administration (FDA) has already granted CLR 131 orphan drug status, which will expedite the drug’s development.
“We continue to see consistently positive outcomes with CLR 131 and this study will further define its clinical benefits in a single and multi-dose regimen for the treatment of multiple myeloma, the results of which will be instrumental in the design of a pivotal trial,” Jim Caruso, president and CEO of Cellectar, said in a news release. “We believe CLR 131 may also provide therapeutic benefits in a number of orphan-designated hematologic cancers, and we designed the Phase 2 study to optimize our understanding of the drug’s clinical utility.”
The Phase 2 trial, which will be funded with a $2 million grant from the National Cancer Institute, will be conducted in up to 15 centers across the U.S. The trial will enroll multiple myeloma patients who received prior treatment with a proteasome inhibitor, such as Ninlaro (ixazomib) or Velcade (bortezomib), and an immunomodulatory drug.
Patients with lymphoma — chronic lymphocytic lymphoma/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL) — who have received at least one standard line of therapy for their disease will also be included in the study.
Participants will receive a single dose of CLR 131 infused over a period of 30 minutes, and will have the option of receiving a second dose 80 to 160 days after the first dose, depending on the physician’s assessment. Multiple myeloma patients will also receive weekly Decadron (dexamethasone) in the first 12 weeks.
The study’s primary endpoint is objective response rate. Secondary endpoints include progression-free survival and other measures of effectiveness that will be determined using the latest International Multiple Myeloma Working Group criteria in myeloma patients and the Lugano criteria in lymphoma patients.