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Also known as CLR 131, Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
Iopofosine I-131 · 6 trials · 24 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.
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
Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse Events Grading (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death)
Adverse Events Grading (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death)
Identify the recommended Phase 2 dose and regimen of CLR 125 in advanced TNBC patients
Adverse Events are graded per NCI CTCAE v5.0
Will be assessed by physical examination, performance status, vital signs, laboratory changes over time, and adverse events. Evaluations will use a nonparametric Wilcoxon Signed Rank test and a linear mixed effects modeling will be conducted to evaluate longitudinal changes.
To determine the therapeutic activity defined as Progression Free Survival (PFS) using Kaplan Meier estimator. PFS is defined as the time from arm assignment until disease progression or death.
DLT will be assessed by physical examination, vital signs, and laboratory values
| Arm | Type | Description |
|---|---|---|
| Iopofosine I 131 | EXPERIMENTAL | Iopofosine I 131 |
| R-CD | ACTIVE_COMPARATOR | Rituximab, cyclophosphamide, dexamethasone |
| 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 |
| CLR 131 Dose Escalation | EXPERIMENTAL | Enrollment will start at dose level 1 (first 4 participants). Participants will receive 2 doses of CLR 131 intravenously with the first dose on day 1 followed by the second dose on day 8. Dose Level -1 (de-escalation dose, if toxicities warrant) = 12.5 mCi/m\^2 Dose Level 1 (beginning dose) = 15.6 mCi/m\^2 Dose Level 2 (escalation dose) = 18.75 mCi/m\^2 Dose escalation will proceed with no limiting toxicities at each level (maximum of 8 participants at each dose level). With maximum tolerated dose confirmed, an expansion phase will proceed. |
| 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, 36, and 37) 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, 36, and 37) 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. Arm 3 is no longer enrolling. |
| Treatment Phase: CLR 125 Arm 4 | EXPERIMENTAL | CLR 125 will be administered at 80 mCi/m2 fractionated over four doses (day 1, 2, 36, and 37) in each 8-week cycle; patient will receive up to 4 cycles. |
| Pediatric High-Grade Glioma Patients | EXPERIMENTAL | Two dosing cohorts will be explored; patients in the first arm will receive two doses, 20 mCi/m2 each, separated by 14 days for two cycles, with a third optional cycle. Patients in the second arm will receive two doses, 10 mCi/m2 each, separated by 14 days for three cycles with a fourth optional cycle. |
| CLR 131 | EXPERIMENTAL | CLR 131 intravenous administration |
| Name | Type | Description |
|---|---|---|
| Iopofosine I 131 | DRUG | Fractionated dose |
| Rituximab (active comparator) | DRUG | Rituximab |
| Cyclophosphamate | DRUG | Cyclophosphamide |
| Dexamethasone | DRUG | Dexamethasone |
| Iopofosine I 131 single dose | DRUG | Radiopharmaceutical |
| Iopofosine I 131 multiple dose | DRUG | Radiopharmaceutical |
| Iopofosine I 131 fractionated dose | DRUG | Radiopharmaceutical |
| CLR 131 | DRUG | CLR 131 is a radiopharmaceutical dosed intravenously over a period of approximately 30 minutes, dose will be based on total body surface area calculated from actual body weight and height |
| 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...
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Iopofosine I-131 is an investigational small molecule radiopharmaceutical being developed for several cancer types. It is studied in Waldenstrom macroglobulinemia, breast cancer, head and neck cancer, high-grade glioma, and pediatric solid tumors. It is not approved and remains in clinical development.
Iopofosine I-131 is being evaluated in Waldenstrom macroglobulinemia, including relapsed, refractory, and nodal disease. The Phase 3 trial NCT07766421 compares it with R-CD in patients with this condition. It is investigational and has not been approved for any indication.
Iopofosine I-131 is being developed by Cellectar Biosciences, Inc., which trades under the ticker CLRB. The company sponsors the clinical program studying the agent across multiple oncology indications, including Waldenstrom macroglobulinemia, breast cancer, head and neck cancer, and high-grade glioma.
Iopofosine I-131 is in clinical development, with studies spanning Phase 1 and Phase 3. The Phase 3 trial NCT07766421 evaluates it in Waldenstrom macroglobulinemia, while Phase 1 studies cover breast cancer, high-grade glioma, and head and neck cancer. It is investigational and not approved.
Iopofosine I-131 has been studied in NCT07766421 for Waldenstrom macroglobulinemia, NCT07311993 for triple negative breast cancer, NCT05610891 for pediatric high-grade glioma, and NCT04105543 for head and neck cancer. These trials include Phase 1 and Phase 3 studies, with enrollment across adult and pediatric populations.
Yes, Iopofosine I-131 is also known as CLR 131. Other names used include Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose, and Iopofosine I 131. These refer to the same investigational radiopharmaceutical developed by Cellectar Biosciences.