Recent Updates
Recently added Catalysts

CLR 131

Phase 1

High-Grade Glioma | Small molecule | Oncology |Cellectar Biosciences, Inc.|Last Updated: Mar 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05610891Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGGPHASE1 ACTIVE NOT_RECRUITING 50 — — Oct 1, 2023Sep 1, 2026Mar 18, 20268 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety Evaluation of CLR 131
Assessed throughout the study to 1-year post-infusion follow-up period

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.

Efficacy Evaluation for Progression Free Survival
Day 84 post-infusion follow-up period through 3 years following completion of treatment.

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.

Secondary Endpoints
Treatment Response of CLR 131
From date of arm assignment until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 48 months.
Dose Determination for CLR 131
From date of arm assignment until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 48 months.
Dosimetry Evaluation for Total Body and Organ
4 hours post-infusion and concluding 4 weeks post-initial imaging
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pediatric High-Grade Glioma PatientsEXPERIMENTALTwo 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.
Interventions
NameTypeDescription
CLR 131DRUGCLR 131 will be administered IV (intravenously) at a dose based on patients' BSA
Unlock Study Design Details
Eligibility Criteria
Age Range10 Years — 25 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Previously confirmed (histologically or cytologically) high grade glioma that is clinically or radiographically suspected to be relapsed, refractory, or recurrent * ≥ 10 years of age and ≤ 25 years of age at time of consent/assent * If ≥ age 16 years, Karnofsky performance sta...

Countries:United StatesCanada
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05610891primaryCompletionDate: changed
LOWMay 24, 2026NCT05610891studyFirstPostDate: changed