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Also known as Iopofosine I 131 single dose
Iopofosine I 131 · 2 trials · 6 indications
A survival analysis will be performed comparing treatment arms using the Cox Proportional Hazard model to determine the hazard ratio, corresponding 95% CI, and p-value to determine superiority between iopofosine I 131 and R-CD.
Identify the recommended Phase 2 dose and regimen of CLR 125 in advanced TNBC patients
Adverse Events are graded per NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Iopofosine I 131 | EXPERIMENTAL | Iopofosine I 131 |
| R-CD | ACTIVE_COMPARATOR | Rituximab, cyclophosphamide, dexamethasone |
| Dosimetry Phase | OTHER | Iopofosine I 131 (CLR 131) will be administered at 10 mCi on day 1 for approximately 15 patients for imaging purposes. |
| Treatment Phase: CLR 125 Arm 1 | EXPERIMENTAL | CLR 125 administered at 65 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 4 cycles. |
| Treatment Phase: CLR 125 Arm 2 | EXPERIMENTAL | CLR 125 will be administered at 125 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 3 cycles. |
| Treatment Phase: CLR 125 Arm 3 | EXPERIMENTAL | CLR 125 will be administered at 190 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 2 cycles. |
| Name | Type | Description |
|---|---|---|
| Iopofosine I 131 | DRUG | Fractionated dose |
| Rituximab (active comparator) | DRUG | Rituximab |
| Cyclophosphamate | DRUG | Cyclophosphamide |
| Dexamethasone | DRUG | Dexamethasone |
| CLR 125 | DRUG | Investigational radiopharmaceutical product intended for IV administration. |
Inclusion Criteria: * Histologically and serologically confirmed diagnosis of WM. * Received at least one prior therapy for WM. * Received treatment with a BTKi (including covalent BTKi or non-covalent BTKi). * Symptomatic disease progression requiring therapy. Specifically, participant must meet o...
Iopofosine I 131 is an investigational small molecule being studied for the treatment of Waldenstrom Macroglobulinemia and Breast Cancer. It is in clinical development for these oncology indications, with trials evaluating its safety and efficacy in patients with these conditions.
Iopofosine I 131 is a radiolabeled small molecule that delivers iodine-131 to cancer cells. It is designed to target and treat B-cell malignancies, including Waldenstrom Macroglobulinemia, by delivering radiation directly to the tumor cells.
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 Phase 1 clinical development. It has received FDA designations including Accelerated Approval, Orphan Drug, Rare Pediatric Disease, Fast Track, and Breakthrough Therapy. The drug is investigational and not yet approved for commercial use.
Iopofosine I 131 is being studied in multiple clinical trials. NCT02952508 is a Phase 2 study in select B-cell malignancies including 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 Macroglobulinemia patients.
No, Iopofosine I 131 is not the same as CLR 125. Iopofosine I 131 is being studied in Waldenstrom Macroglobulinemia and other B-cell malignancies, while CLR 125 is a separate investigational drug being evaluated in a Phase 1 trial for triple negative breast cancer.