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Active, not recruiting Phase 1

Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG

NCT05610891 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2023-10-01
Last updated
2026-10-01

Condition(s) studied

High-Grade Glioma

Investigational drug(s) / intervention(s)

CLR 131 →

CLR 131: CLR 131 will be administered IV (intravenously) at a dose based on patients' BSA

Study summary

The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).

Eligibility

Sex
ALL
Min age
10 Years
Max age
25 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (8)

FacilityCityRegionStatus
Stanford University Palo Alto California
Memorial Sloan Kettering Cancer Center New York New York
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Children's Hospital of Philadelphia Philadelphia Pennsylvania
UT Southwestern Medical Center Dallas Texas
Texas Children's Cancer Center, Baylor College of Medicine Houston Texas
University of Wisconsin, Carbone Cancer Center Madison Wisconsin
Hospital for Sick Children Toronto Ontario
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05610891 on ClinicalTrials.gov ↗ ← All trials in the USA