Drugs / I-131-CLR1404
I-131-CLR1404
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 1 met primary | ||||||
| Phase 1 | NCT07311993 | Dec 2025 → Feb 2028 expected | breast cancer | Cellectar Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05610891 | Oct 2023 → May 2026 overdue | malignant glioma | Cellectar Biosciences, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04105543 | Dec 2019 → Sep 2022 | head and neck cancer | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1 | NCT03478462 | Apr 2019 → Aug 2026 overdue | Ewing sarcoma, diffuse intrinsic pontine glioma, neuroblastoma, osteosarcoma +2 | Cellectar Biosciences, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02278315 | Feb 2015 → Dec 2020 | plasma cell myeloma | Cellectar Biosciences, Inc. | Completed | Met primary |
| Phase 1 | NCT01495663 | Dec 2011 → Nov 2013 | cancer | Cellectar Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00925275 | Jun 2009 → Feb 2010 | cancer | Cellectar, Inc | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT02952508 | Jul 2017 → Jun 2026 overdue | Waldenstrom macroglobulinemia, central nervous system non-hodgkin lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma +3 | Cellectar Biosciences, Inc. | Active not recruiting | Met primary |
| Phase 2 | NCT01778088 | May → Jun 2014 | glioma | Cellectar Biosciences, Inc. | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 63
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Announces Publication of Phase 1 Study of Iopofosine I 131 in Peer-Reviewed Journal Cancers cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the publication of results from a Phase 1 dose-escalation study evaluating iopofosine I 131 in combination with low-dose dexamethasone in 31 patients with heavily pretreated relapsed/refractory multiple myeloma (r/r MM). |
| 2026-06-01 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences to Highlight Compelling New Efficacy Data from Phase 2b CLOVER WaM Study of Iopofosine I 131 in r/r Waldenström Macroglobulinemia at the American Society of Clinical Oncology Annual Meeting cellectar.com ↗
We are highly encouraged by these results from the CLOVER WaM study, which demonstrate compelling efficacy and durable responses with iopofosine I 131 in the particularly challenging patient population that has progressed following BTKi therapy. |
| 2026-05-05 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Reports Positive 12-Month Follow-Up Data from Phase 2b CLOVER WaM Study Demonstrating Durable Responses and Efficacy of Iopofosine I 131 in r/r Waldenström Macroglobulinemia cellectar.com ↗ |
| 2025-10-27 | Cellectar Biosciences, Inc. | Regulatory Cellectar Biosciences Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Iopofosine I 131 in Relapsed or Refractory Pediatric High-Grade Glioma cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) has granted rare pediatric drug designation (RPDD) for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG). |
| 2025-10-06 | Cellectar Biosciences, Inc. | Regulatory Cellectar Biosciences Announces European Medicines Agency (EMA) Confirms Eligibility to File for Conditional Marketing Authorization (CMA) for Iopofosine I 131 as a Treatment for Refractory (post-BTKi) Waldenstrom Macroglobulinemia (WM) cellectar.com ↗ |
| 2025-09-30 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Presented Compelling Data in Oral Session and Panel Discussions at the American Association for Cancer Research Special Conference on Discovery and Innovation in Pediatric Cancer cellectar.com ↗
The oral presentation highlighted interim data from the Phase 1b dose and regimen optimization study of iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG). |
| 2025-06-11 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Provides Update on CLOVER-2 Phase 1 Clinical Trial of Iopofosine I 131 in Pediatric Patients with Relapsed/Refractory High-Grade Glioma cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced initial results as of June 10, 2025, from the CLOVER-2 Phase 1 clinical trial evaluating iopofosine I 131 in relapsed/refractory pediatric high-grade glioma (pHGG) patients. |
| 2025-06-04 | Cellectar Biosciences, Inc. | Regulatory Cellectar Granted U.S. FDA Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM) cellectar.com ↗
the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for iopofosine I 131 |
| 2024-07-23 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences’ Iopofosine I 131 Exceeds Primary Endpoint in Waldenstrom’s Macroglobulinemia Pivotal Study with 78% of Major Response Patients Remaining Progression Free at 18 Months cellectar.com ↗ |
| 2024-03-04 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Reports High Rate of Complete Remission in Investigator Initiated Phase I Study of Iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer cellectar.com ↗
Complete remission was achieved in 64% of patients, with an ORR of 73% (n=11). |
| 2024-01-22 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Reports Complete Central Nervous System (CNS) Clearance in Relapsed/Refractory Waldenstrom’s Macroglobulinemia Patient cellectar.com ↗ |
| 2024-01-08 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Announces Positive Topline Data Achieving Primary Endpoint in Pivotal Clinical Study of Iopofosine I 131 in Waldenstrom’s Macroglobulinemia cellectar.com ↗
The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61% (95% confidence interval [44.50%, 75.80%, two-sided p value < 0.0001]). |
| 2023-10-02 | Cellectar Biosciences, Inc. | Regulatory Cellectar Biosciences Expands Global Intellectual Property Portfolio with Four Patent Grants cellectar.com ↗
The European Patent Office (EPO) has granted patent application number 20172745.0, titled “ Ether Phospholipid Compounds for Treating Cancer and Imaging Detection of Cancer Stem Cells”. |
| 2023-09-18 | Cellectar Biosciences, Inc. | Regulatory Cellectar Biosciences Receives European Medicines Agency Priority Medicines (PRIME) Designation for Iopofosine for Waldenstrom’s Macroglobulinemia cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to iopofosine I 131, the company’s lead small-molecule drug candidate, for Waldenstrom’s macroglobulinemia (WM) in patients who have received two or more prior treatment regimens. |
| 2023-02-28 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Reports Complete Response in a Relapsed/Refractory CNS Lymphoma Patient cellectar.com ↗
The patient was administered the second cycle of iopofosine I 131 on days 57 and 71 and demonstrated complete resolution of the tumor as determined by CT scan by day 92 from initial dosing. |
| 2022-04-26 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Announces Positive DMC Review of Pivotal Trial of Iopofosine in Waldenstrom’s Macroglobulinemia cellectar.com ↗
today announced an independent Data Monitoring Committee (DMC) has completed its planned futility/efficacy assessment of the company’s pivotal Phase 2b study of iopofosine in Waldenstrom’s macroglobulinemia (WM) and unanimously recommended continuation of the trial as planned. |
| 2021-11-16 | Cellectar Biosciences, Inc. | Results Cellectar’s Iopofosine I-131 Exhibits Signals of Efficacy in Phase I Study for Pediatric Brain and Solid Tumors cellectar.com ↗
The initial response and tumor uptake were confirmed by further therapeutic responses, evidenced by changes in tumor parameters. |
| 2021-06-04 | Cellectar Biosciences, Inc. | Results Cellectar Presents Data in Waldenstrom’s Macroglobulinemia in Poster at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting cellectar.com ↗
To date, data have shown: 100% (6/6) overall response rate, 83.3% (5/6) major response rate and a 16.7% (1/6) complete response rate |
| 2021-01-27 | Cellectar Biosciences, Inc. | Regulatory Cellectar Receives Orphan Drug Designation from the European Commission for CLR 131 in Waldenstrom’s Macroglobulinemia cellectar.com ↗
today announced that the European Medicines Agency has adopted a positive opinion for CLR 131 orphan designation for the treatment of Waldenstrom’s Macroglobulinemia (WM). |
| 2020-11-05 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences’ CLR 131 Demonstrates Preliminary Activity in Phase I Study for Pediatric Brain and Solid Tumors cellectar.com ↗ |
| 2020-09-09 | Cellectar Biosciences, Inc. | Results Cellectar Reports Data on CLR 131 Phase 2 CLOVER-1 Study in Triple Class Refractory Multiple Myeloma Patients cellectar.com ↗
today announced that a clinically meaningful 40% overall response rate (ORR) was observed in the subset of refractory multiple myeloma patients deemed triple class refractory who received a total administered dose of 60 mCi or greater. |
| 2020-08-17 | Cellectar Biosciences, Inc. | Results Cellectar Presents Poster at the AACR VIRTUAL MEETING: ADVANCES IN MALIGNANT LYMPHOMA cellectar.com ↗
Interim results show 100% overall response rate and a 75% major response rate |
| 2020-07-21 | Cellectar Biosciences, Inc. | Results Cellectar Announces Poster Presentation of Clinical Data at the American Association of Cancer Research (AACR) Annual Meeting cellectar.com ↗
Poster Title CLR 131 Demonstrates 100% Overall Response Rate in Relapsed or Refractory Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom’s Macroglobulinemia (WM): Initial Results from Ongoing Phase 2 trial, CLOVER-1 Study |
| 2020-05-26 | Cellectar Biosciences, Inc. | Regulatory Cellectar Receives FDA Fast Track Designation for CLR 131 in Lymphoplasmacytic Lymphoma/Waldenstrom’s Macroglobulinemia cellectar.com ↗
today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CLR 131 in lymphoplasmacytic lymphoma (LPL)/Waldenstrom’s macroglobulinemia (WM) in patients having received two prior treatment regimens or more. |
| 2020-02-19 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Announces CLR 131 Achieves Primary Efficacy Endpoints from Its Phase 2 CLOVER-1 Study in Relapsed/Refractory B-cell Lymphomas and Completion of the Phase 1 Relapsed/Refractory Multiple Myeloma Dose Escalation Study cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced positive data from its Phase 2 CLOVER-1 study in patients with relapsed/refractory B-cell lymphomas. |
| 2020-01-06 | Cellectar Biosciences, Inc. | Regulatory Cellectar Receives Orphan Drug Designation for CLR 131 in Lymphoplasmacytic Lymphoma (LPL) cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131 in Lymphoplasmacytic Lymphoma (LPL). |
| 2019-12-16 | Cellectar Biosciences, Inc. | Results Cellectar Announces Data From 20 Patients Receiving a Single 25mCi/M2 Bolus Dose of CLR 131 in the Phase 2 CLOVER-1 Study cellectar.com ↗
Data from these 20 patients showed a 30% ORR, a 75% clinical benefit rate, an average progression free survival of 4.5 months and an acceptable and expected safety profile. |
| 2019-12-09 | Cellectar Biosciences, Inc. | Results Fractionated Dosing of CLR 131 in Patients with Relapsed or Refractory Multiple Myeloma Presented at the 61st Annual American Society of Hematology Conference cellectar.com ↗
The overall response rate (ORR) for all multiple myeloma patients across the 3 dose cohorts was 31.3% and a 100% disease control rate. |
| 2019-09-30 | Cellectar Biosciences, Inc. | Results Cellectar Presents Data from DLBCL Cohort of its Phase 2 CLOVER-1 Study at the European Society for Medical Oncology (ESMO) Congress cellectar.com ↗
Data showed durable responses, including a 33% overall response rate (ORR), a 16.6% complete response rate (CR) and a 50% clinical benefit rate (CBR). |
| 2019-09-24 | Cellectar Biosciences, Inc. | Regulatory Cellectar Receives Orphan Drug Designation from the European Commission for CLR 131 in Multiple Myeloma cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that the European Commission has awarded CLR 131 orphan designation for the treatment of multiple myeloma. |
| 2019-09-16 | Cellectar Biosciences, Inc. | Results Cellectar Presents Data from Cohort 6 of its CLR 131 Phase 1 Study in Patients with Relapsed or Refractory Multiple Myeloma cellectar.com ↗
Subjects in this cohort achieved a 50% overall response rate, with two subjects achieving a partial response and two subjects achieving minimal responses (39% and 48% reduction in M protein). |
| 2019-08-14 | Cellectar Biosciences, Inc. | Results CLR 131 Advances to Second Malignant Brain Tumor Cohort of Ongoing Pediatric Phase 1 Study cellectar.com ↗
The independent Data Monitoring Committee determined the 15mCi/m 2 bolus dose to be safe and tolerated and recommended the company progress to a second cohort utilizing a 30 mCi/m 2 bolus dose of CLR 131. |
| 2019-08-12 | Cellectar Biosciences, Inc. | Results Cellectar Reports Second Quarter 2019 Financial Results and Provides a Corporate Update cellectar.com ↗
Announced initial results from Cohort 6 in the company’s ongoing Phase 1 clinical study with CLR 131 in Relapsed or Refractory Multiple Myeloma (R/R MM). |
| 2019-07-09 | Cellectar Biosciences, Inc. | Regulatory Cellectar Receives FDA Fast Track Designation for CLR 131 in Diffuse Large B-Cell Lymphoma cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). |
| 2019-05-21 | Cellectar Biosciences, Inc. | Results Cellectar Expands Third Cohort of its Phase 2 CLOVER-1 Study of CLR 131 cellectar.com ↗
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced that initial results from the third cohort of its ongoing Phase 2 CLOVER-1 study of CLR 131 have exceeded its pre-specified performance criteria. |
| 2019-05-15 | Cellectar Biosciences, Inc. | Results CLR 131 Achieves 50% Overall Response Rate in Cohort 6 of Ongoing Phase 1 Study in Relapsed or Refractory Multiple Myeloma cellectar.com ↗
Data from Cohort 6 showed improved efficacy and a clear dose response compared to prior cohorts, including a 50% partial response rate, a 50% minimal response rate and 100% disease control rate. |
| 2019-05-13 | Cellectar Biosciences, Inc. | Regulatory Cellectar Receives FDA Fast Track Designation for CLR 131 in Relapsed or Refractory Multiple Myeloma cellectar.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CLR 131 in fourth line or later relapse/refractory multiple myeloma. |
| 2019-05-06 | Cellectar Biosciences, Inc. | Results Cellectar Reports First Quarter 2019 Financial Results and Provides a Corporate Update cellectar.com ↗
In the cohort, CLR 131 achieved a 30% overall response rate in the first 10 evaluable patients. |
| 2019-03-19 | Cellectar Biosciences, Inc. | Regulatory FDA Grants Exemption to Import Alert for Cellectar’s CLR 131 in Pediatric and Adolescent Patients cellectar.com ↗
the U.S. Food and Drug Administration (FDA) has granted an exemption to the Import Alert placed on the Centre for Probe Development and Commercialization (CPDC) for the use of CLR 131 in connection with the company’s pediatric IND. |
| 2019-02-26 | Cellectar Biosciences, Inc. | Results Cellectar Reports Financial Results for Year Ended December 31, 2018 and Provides a Corporate Update cellectar.com ↗
In patients with an average of 5 prior lines of systemic therapy, CLR 131 achieved a 30% overall response rate in the first 10 evaluable patients. |
| 2019-02-25 | Cellectar Biosciences, Inc. | Results Cellectar Reports Positive Top-line Response Rate of 30% from R/R Multiple Myeloma Cohort in Ongoing Phase 2 Study of CLR 131 cellectar.com ↗
In the relapse refractory multiple myeloma cohort, CLR 131 achieved a 30% overall response rate in the first 10 evaluable patients. |
| 2019-01-07 | Cellectar Biosciences, Inc. | Results Cellectar Provides Update on Phase 1 Trial of CLR 131 in Relapsed/Refractory Multiple Myeloma cellectar.com ↗
The results showed mOS of 22.0 months among 15 patients, all of whom were heavily pretreated, averaging five prior lines of systemic therapy. |
| 2018-11-12 | Cellectar Biosciences, Inc. | Regulatory Cellectar Announces FDA Grants Exemption to Import Alert for CLR 131 Hematology Studies cellectar.com ↗ |
| 2018-10-02 | Cellectar Biosciences, Inc. | Results Cellectar Announces Overall Survival Exceeding 19 Months in Phase 1b Trial with CLR 131 in Relapsed/Refractory Multiple Myeloma cellectar.com ↗
The results to date show that OS is currently at 19.4 months. |
| 2018-09-25 | Cellectar Biosciences, Inc. | Regulatory Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for the Treatment of Pediatric Osteosarcoma cellectar.com ↗ |
| 2018-09-24 | Cellectar Biosciences, Inc. | Regulatory Cellectar Biosciences Provides an Update on the FDA Import Alert cellectar.com ↗
Recently, the FDA initiated direct talks with Cellectar on a potential pathway to remove CLR 131 from the Import Alert and allow CPDC to resume supply of CLR 131. |
| 2018-09-17 | Cellectar Biosciences, Inc. | Regulatory FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatment of Osteosarcoma cellectar.com ↗
Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131 for the treatment of osteosarcoma, a rare pediatric cancer. |
| 2018-08-20 | Cellectar Biosciences, Inc. | Results Fractionated Dosing Improves Tolerability and Safety of Cellectar’s CLR 131 in R/R Multiple Myeloma Patients cellectar.com ↗
Results from Cohort 5 indicate enhanced tolerability and safety in comparison to Cohort 4 despite an 18% increase in total average dose from 55.29 mCi to 65.15 mCi of CLR 131. |
| 2018-08-13 | Cellectar Biosciences, Inc. | Regulatory Cellectar’s CLR 131 Receives FDA Rare Pediatric Disease Designation for the Treatment of Ewing’s Sarcoma cellectar.com ↗
Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131, the company’s lead Phospholipid Drug Conjugate™ (PDC) product candidate, for the treatment of Ewing’s sarcoma, a rare pediatric cancer. |
| 2018-07-18 | Cellectar Biosciences, Inc. | Results Cellectar Reports Positive Phase 2 Interim Data for CLR 131 in Relapsed/Refractory DLBCL Patients cellectar.com ↗
These interim data show a 33% overall response rate (ORR) and a 50% clinical benefit response (CBR). |
| 2018-07-17 | Cellectar Biosciences, Inc. | Results Cellectar Reports 94% Reduction in Overall Tumor Volume in Waldenstrom Macroglobulinemia Patient in Phase 2 CLR 131 Clinical Study cellectar.com ↗
today announces that a patient in the lymphoplasmacytic lymphoma (LPL) arm with advanced Waldenstrom macroglobulinemia, enrolled in the CLR 131 Phase 2 trial, showed a 94% reduction in tumor burden and complete resolution in four of five targeted tumor masses. |
| 2018-07-09 | Cellectar Biosciences, Inc. | Regulatory Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for Treatment of Ewing’s Sarcoma cellectar.com ↗ |
| 2018-06-28 | Cellectar Biosciences, Inc. | Results Cellectar Announces Expansion of Diffuse Large B-Cell Lymphoma Cohort in CLR 131 Phase 2 Trial cellectar.com ↗
The response rate of the DLBCL cohort exceeded pre-specified criteria. |
| 2018-06-06 | Cellectar Biosciences, Inc. | Regulatory FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatment of Rhabdomyosarcoma cellectar.com ↗
Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131, the company’s lead Phospholipid Drug Conjugate™ (PDC) product candidate, for the treatment of rhabdomyosarcoma, a rare pediatric cancer. |
| 2018-05-09 | Cellectar Biosciences, Inc. | Regulatory Cellectar Granted Orphan Drug Designation for CLR 131 to Treat Rhabdomyosarcoma cellectar.com ↗
Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to CLR 131, the company’s lead Phospholipid Drug Conjugate™ (PDC) product candidate, for the treatment of rhabdomyosarcoma, a rare pediatric cancer. |
| 2018-05-02 | Cellectar Biosciences, Inc. | Regulatory Cellectar Receives Rare Pediatric Disease Designation for CLR 131 to Treat Neuroblastoma cellectar.com ↗
announces today that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation (RPDD) to the company’s lead phospholipid drug conjugate, CLR 131, for the treatment of neuroblastoma. |
| 2018-04-17 | Cellectar Biosciences, Inc. | Results Cellectar Presents Preclinical Data at AACR Annual Meeting Demonstrating Efficacy of Fractionated Injections of CLR 131 in Multiple Myeloma cellectar.com ↗
Additionally, the time it took for tumors to double in size was markedly increased using fractionated dosing in comparison to the other treatments. |
| 2018-04-16 | Cellectar Biosciences, Inc. | Results Preclinical Data Highlighting Uptake and Enhanced Anti-Tumor Effects of Cellectar’s CLR 131 in Head and Neck Cancer Presented at AACR Annual Meeting cellectar.com ↗
The results demonstrated uptake of CLR 131 across multiple head and neck cancer (HNC) cell lines and xenograft models, and synergistic anti-tumor effects when CLR 131 was combined with XRT. |
| 2018-03-19 | Cellectar Biosciences, Inc. | Regulatory Cellectar Biosciences Granted Orphan Drug Designation for CLR 131 to Treat Neuroblastoma cellectar.com ↗ |
| 2017-12-14 | Cellectar Biosciences, Inc. | Regulatory Cellectar Files IND for Phase 1 Trial of CLR 131 in Pediatric Cancers cellectar.com ↗ |
| 2017-12-06 | Cellectar Biosciences, Inc. | Results Cellectar Announces Expansion of Relapsed/Refractory Multiple Myeloma Cohort in Phase 2 Trial of CLR 131 cellectar.com ↗
Data from the MM cohort of the study demonstrated that the treatment exceeded pre-specified criteria for clinically meaningful benefit. |
| 2017-11-07 | Cellectar Biosciences, Inc. | Results Cellectar Announces Updated Median Overall Survival of 26.2 Months from Cohort 1 of CLR 131 Phase 1 Trial in Advanced Multiple Myeloma cellectar.com ↗
today announces that the ongoing median overall survival (mOS) from Cohort 1 of the Phase 1 study of its lead PDC™ compound, CLR 131 has reached 26.2 months in patients with multiple myeloma. |
| 2017-09-27 | Cellectar Biosciences, Inc. | Results Cellectar Biosciences Reports Cohort Four Data and Partial Response in Relapsed or Refractory Multiple Myeloma Patient Treated with CLR 131 cellectar.com ↗
today announces that a patient treated with the company’s lead PDC™ compound, CLR 131 in the fourth cohort of its Phase I dose escalation safety trial in relapse or refractory multiple myeloma achieved a partial response (PR). |
All press releases naming this drug 82 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | I-131-CLR1404 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00925275 ↗ |
| Known as | CLR 131 | “Iopofosine I 131 (CLR 131) is a targeted small molecular phospholipid ether (PLE) drug conjugate that delivers iodine-131 selectively to tumour cells.” PMID 39671752 ↗ Dec 2024 |
| Known as | Iopofosine I 131 | “Iopofosine I 131 (CLR 131) is a targeted small molecular phospholipid ether (PLE) drug conjugate that delivers iodine-131 selectively to tumour cells.” PMID 39671752 ↗ Dec 2024 |
| Modality | Small molecule | “I-131-CLR1404 is a small molecule” NCT00925275 ↗ |
| Route | Intravenous | “Single intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0” NCT00925275 ↗ |