Drugs / I-131-CLR1404

Trials 9

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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Phase 2 NCT01778088 May → Jun 2014 glioma Cellectar Biosciences, Inc. Withdrawn No outcome recorded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

DateIssuerRelease
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]).

All press releases naming this drug 82 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as I-131-CLR1404 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00925275 ↗
3

NCT02278315 ↗

NCT01778088 ↗

NCT01495663 ↗

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
2

NCT05610891 ↗

NCT03478462 ↗

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
2

NCT07311993 ↗

NCT02952508 ↗

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 ↗