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Radiopharmaceutical

Targeted Radiotherapy for Brain Tumor

Phase 1
Recruiting
Research Sponsored by Cellectar Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed throughout the study to 1-year post-infusion follow-up period
Awards & highlights
No Placebo-Only Group

Summary

This trial tests higher doses of a new drug to see if it is safe and effective for treating kids, teens, and young adults with HGG.

Who is the study for?
This trial is for children, adolescents, and young adults aged 2-25 with high-grade glioma (a type of brain tumor) that has come back or hasn't responded to treatment. They must be in a stable condition, not pregnant, able to follow the study plan, and have certain blood counts and organ functions within specific ranges.
What is being tested?
The trial is testing two different doses of CLR 131 to see how safe it is and if it works against relapsed or refractory high-grade gliomas in pediatric patients. It's a dose-finding study which means they're trying to find the right amount of drug that's effective but also safe.
What are the potential side effects?
While the exact side effects are not listed here, similar targeted radiotherapies can cause nausea, fatigue, loss of appetite, hair loss at the site of treatment. There may also be risks associated with radiation exposure such as damage to healthy tissue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed throughout the study to 1-year post-infusion follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed throughout the study to 1-year post-infusion follow-up period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy Evaluation for Progression Free Survival
Safety Evaluation of CLR 131
Secondary study objectives
Dose Determination for CLR 131
Dosimetry Evaluation for Total Body and Organ
Treatment Response of CLR 131
+1 more

Side effects data

From 2024 Phase 1 trial • 12 Patients • NCT04105543
92%
White blood cell decreased
83%
Lymphocyte count decreased
83%
Neutrophil count decreased
83%
Anemia
75%
Platelet count decreased
67%
Fatigue
50%
Mucositis oral
50%
Dermatitis radiation
42%
Dry mouth
42%
Anorexia
33%
Dysphagia
33%
Weight loss
33%
Headache
25%
Nausea
25%
Oral Pharyngeal pain
25%
Hypotension
17%
Mucosal infection
17%
Febrile neutropenia
17%
Dizziness
17%
Pain
17%
Dysgeusia
17%
Constipation
8%
Syncope
8%
Tumor hemorrhage
8%
Depression
8%
Salivary duct inflammation
8%
Watering eyes
8%
Vomiting
8%
Epistaxis
8%
Respiratory failure
8%
Diarrhea
8%
Neck Pain
8%
Aspiration
8%
Neuralgia
8%
Stridor
8%
Fever
8%
Neck edema
8%
Thrush
8%
Tinnitus
8%
Dehydration
8%
Trismus
8%
Paresthesia
8%
Chills
8%
Erythema multiforme
8%
Dyspnea
8%
Thyroid stimulating hormone increased
8%
Rash Maculo-papular
8%
Fibrosis deep connective tissue
8%
Osteonecrosis of jaw
8%
Tumor pain
8%
Dry eye
8%
Superficial thrombophlebitis
8%
Dysarthria
8%
Metabolism and nutrition disorders - Other, specify
8%
Hypoxia
8%
Hypertension
8%
Laryngitis
8%
Lymphedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
CLR 131 Dose Escalation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pediatric High-Grade Glioma PatientsExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLR 131
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Cellectar Biosciences, Inc.Lead Sponsor
14 Previous Clinical Trials
1,215 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,530 Total Patients Enrolled
Jarrod LongcorStudy DirectorChief Operating Officer
2 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

CLR 131 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05610891 — Phase 1
Brain Tumor Research Study Groups: Pediatric High-Grade Glioma Patients
Brain Tumor Clinical Trial 2023: CLR 131 Highlights & Side Effects. Trial Name: NCT05610891 — Phase 1
CLR 131 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05610891 — Phase 1
~26 spots leftby May 2026