New radiation drug targets brain tumors in kids
NCT ID NCT05610891
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called CLR 131, a targeted radiotherapy, in children, adolescents, and young adults (ages 10 to 25) with high-grade glioma that has returned or not responded to treatment. The goal is to find the best dose and see if it is safe and can shrink tumors or slow the disease. About 50 participants will receive the drug intravenously, and their progress will be tracked with MRI scans and safety checks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CLR 131 (iopofosine I 131), a targeted radiotherapy drug given intravenously
- What this could lead to
- If it works, this could provide a new treatment option for young patients with high-grade glioma that has come back or not responded to standard therapy.
- What could go wrong
- This is an early phase 1b trial with only 50 participants, so the results may not confirm effectiveness. The drug also carries risks like radiation-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 status of ≥ 60. If \< age 16 years, Lansky performance status ≥ 60 * Platelets ≥ 75,000/μL (last transfusion, if any, must be at least 1 week prior to study registration, and, unless deemed medically necessary, no transfusions are allowed between registration and dosing) * Absolute neutrophil count ≥ 750/μL * Hemoglobin ≥ 8 g/dL (last transfusion must be at least 1 week prior to study registration, and, unless deemed medically necessary, no transfusions are allowed between registration and dosing) * Using the bedside Schwartz formula, estimated GFR (creatinine clearance) \> 60 ml/min/1.73m2 * Alanine aminotransferase \< 3 × ULN * Bilirubin \< 2 × ULN * At least 1 measurable intracranial lesion with longest diameter of at least 10 mm on any imaging sequence. * Patients with previously known neurological deficits must be clinically stable at time of enrollment and able to complete all study related procedures. Patients with documented or newly diagnosed neurological deficits will be enrolled at the investigator's discretion. * If patient receives steroids for neurological symptom control, the dose must be stable (unchanged for three weeks prior to registration) or on a steroid tapering regimen. Initiation of steroids per routine care immediately prior to CLR 131 dosing is acceptable * Patient or his or her legal representative is judged by the Investigator to have the initiative and means to be compliant with the protocol. * Patient or his or her legal representative has the ability to read, understand, and provide written informed consent for the initiation of any study-related procedures. * Female patients of childbearing potential must have a negative pregnancy test at screening and within 24 hours of dosing. It is recommended that female caregivers of childbearing potential have a negative pregnancy test within one week of dosing. * Patients of childbearing potential must practice an effective method of birth control while participating on this study to avoid possible harm to the fetus. Exclusion Criteria: * Antitumor therapy or investigational therapy, within 3-half-lives of the agent preceding the present study. For certain types of radiation (craniospinal, total abdominal, whole lung \[spot irradiation to skull-based metastases is not considered craniospinal radiation for the purposes of this study\]), at least 3 months must have elapsed. Palliative focal radiation to non-target lesions should be completed at least 2 weeks prior to dosing. Patients participating in non-interventional clinical trials (i.e., non-drug) are allowed to participate in this trial * History of hypersensitivity to thyroid protection medication (e.g., potassium iodide, Lugol's solution, etc.) * Any other concomitant serious illness or organ system dysfunction (including cardiac and pulmonary dysfunction) that in the opinion of the Investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug. * Major surgery within 6 weeks of enrollment unless delay in therapy poses unacceptable risk to the patient due to clinical progression (enrollment o such patients should be discussed with Medical Monitor) * Known history of human immunodeficiency virus or uncontrolled, serious, active infection * Pregnancy or breast-feeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Stanford University
Palo Alto, California, 94304, United States
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Texas Children's Cancer Center, Baylor College of Medicine
Houston, Texas, 77030, United States
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of Wisconsin, Carbone Cancer Center
Madison, Wisconsin, 53705, United States
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