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I-131-CLR1404

Phase 1

Multiple Myeloma | Small molecule | Oncology |Cellectar Biosciences, Inc.|Last Updated: Feb 22, 2023

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical trial landscape

I-131-CLR1404 · 3 trials · 3 indications

Phase 1 3
NCT00925275Dosimetry Study of I-131-CLR1404 in Patients With Relapsed or Refractory Advanced Solid TumorsSolid Tumors
COMPLETED9 Analytics
NCT02278315Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple MyelomaMultiple Myeloma
COMPLETED31 Analytics
NCT01495663Dose Escalation Study of I-131-CLR1404 in Subjects With Cancer That Does Not Respond to Treatment or Has ReturnedCancer
COMPLETED12 Analytics
PHASE1COMPLETED
Dosimetry Study of I-131-CLR1404 in Patients With Relapsed or Refractory Advanced Solid Tumors
Solid Tumors
NCT009252759
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PHASE1COMPLETED
Dose Escalation Study of I-131-CLR1404 in Patients With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
NCT0227831531
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PHASE1COMPLETED
Dose Escalation Study of I-131-CLR1404 in Subjects With Cancer That Does Not Respond to Treatment or Has Returned
Cancer
NCT0149566312
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Study Endpoints
Primary Endpoints
Number of participants with dose limiting toxicities (DLT)
up to 85 days

DLT will be assessed by physical examination, vital signs, ECG, and laboratory values

Determination of the recommended dose of I-131-CLR1404 in treating subjects with relapsed or refractory advanced solid malignancies
Until non-tolerated dose is defined; dose escalation descision made upon review of data from a complete cohort (56 days after all subjects in cohort have received therapy infusion)

Largest administered dose with at most a 20% dose limiting toxicity rate

Secondary Endpoints
Identification of recommended phase 2 dose of I-131-CLR1404 with concurrent weekly dexamethasone
until non-tolerated dose is defined; dose escalation descision made upon review of data from a complete cohort (85 days after all subjects in cohort have received infusion)
Identification of recommended phase 2 dose of I-131-CLR1404 without dexamethasone
until non-tolerated dose is defined; dose escalation descision made upon review of data from a complete cohort (85 days after all subjects in cohort have received infusion)
Identify the recommended dosing schedule of I-131-CLR1404, in relapsed or refractory MM
until non-tolerated dose is defined with both dosing regimens; dose escalation decision made upon review of data from a complete cohort (85 days after all subjects in cohort have received infusion)
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Study Design & Arms
Treatment Arms
ArmTypeDescription
SingleEXPERIMENTALI-131-CLR1404 with or without concurrent dexamethasone
Single GroupOTHERI-131-CLR1404
Interventions
NameTypeDescription
I-131-CLR1404DRUGSingle intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0
dexamethasoneDRUG40 mg dexamethasone orally once weekly for up to 12 weeks
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Eligibility Criteria
Age Range18 Years to N/A
SexALL

Inclusion Criteria: * Histologically or cytologically confirmed multiple myeloma * Prior treatment with or intolerance to proteasome inhibitor and immunomodulator * Bone marrow biopsy within 28 days of study drug infusion demonstrating at least 5% plasma cell involvement * Progressive disease defin...

Countries:United States
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Competitive Landscape -Multiple Myeloma 222 trials

Top 20 of 26 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Bortezomib, Dexamethasone, Lenalidomide, Cilta-cel, Cyclophosphamide
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol / Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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