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Also known as Iopofosine I 131
Iopofosine I 131 single dose · 1 trial · 9 indications
Response assessment per International Uniform Response Criteria for Multiple Myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic Lymphocytic Leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Criteria for CNS Lymphoma
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
| Arm | Type | Description |
|---|---|---|
| Iopofosine I 131, intravenous administration WM | EXPERIMENTAL | Iopofosine I 131 in Waldenstroms Macroglobulinemia |
| Iopofosine I 131, intravenous administration MM | EXPERIMENTAL | Iopofosine I 131 in Multiple Myeloma |
| Iopofosine I 131, intravenous administration CNS Lymphoma | EXPERIMENTAL | Iopofosine I 131 in Central Nervous System Lymphoma |
| Iopofosine I 131 intravenous administration NHL [CLOSED] | EXPERIMENTAL | Iopofosine I 131 in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma |
| Name | Type | Description |
|---|---|---|
| Iopofosine I 131 single dose | DRUG | Radiopharmaceutical |
| Iopofosine I 131 multiple dose | DRUG | Radiopharmaceutical |
| Iopofosine I 131 fractionated dose | DRUG | Radiopharmaceutical |
\[CLOVER-1\] Inclusion Criteria: All Patients * Histologically or cytologically confirmed MM; Patients with primary or secondary CNSL may be enrolled. * ECOG performance status of 0 to 2 * 18 years of age or older * Life expectancy of at least 6 months * Platelets ≥ 75,000/µL (if full-dose anticoag...
Iopofosine I 131 is an investigational small molecule being developed for oncology indications, including Waldenstrom macroglobulinaemia (also spelled Waldenstrom macroglobulinemia) and breast cancer. It is currently in clinical development for these conditions, with trials evaluating its use in B-cell malignancies and triple negative breast cancer.
Iopofosine I 131 is being developed by Cellectar Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLRB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
Iopofosine I 131 is in clinical development across multiple phases. A Phase 1 study is recruiting for triple negative breast cancer, a Phase 2 study (CLOVER-1) is active but not recruiting for B-cell malignancies, and a Phase 3 study is not yet recruiting for Waldenstrom macroglobulinaemia. The drug is investigational and not yet approved.
Iopofosine I 131 is being evaluated in several trials. NCT02952508 is a Phase 2 study in select B-cell malignancies with expansion in Waldenstrom macroglobulinemia. NCT07311993 is a Phase 1 study in triple negative breast cancer. NCT07766421 is a Phase 3 study comparing Iopofosine I 131 to R-CD in Waldenstrom macroglobulinaemia patients.
No, Iopofosine I 131 is not the same as CLR 125. Iopofosine I 131 is being studied in B-cell malignancies and Waldenstrom macroglobulinaemia, while CLR 125 is a separate investigational drug being evaluated in a Phase 1 study for triple negative breast cancer (NCT07311993). Both are developed by Cellectar Biosciences.
Iopofosine I 131 has received several FDA designations, including accelerated approval, orphan drug, rare pediatric disease, fast track, and breakthrough therapy. These designations are intended to expedite the development and review of the drug for serious or life-threatening conditions.