Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CLR 131 · 3 trials · 10 indications
Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse Events Grading (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death)
Adverse Events Grading (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death)
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.
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.
DLT will be assessed by physical examination, vital signs, and laboratory values
| Arm | Type | Description |
|---|---|---|
| CLR 131 Dose Escalation | EXPERIMENTAL | Enrollment will start at dose level 1 (first 4 participants). Participants will receive 2 doses of CLR 131 intravenously with the first dose on day 1 followed by the second dose on day 8. Dose Level -1 (de-escalation dose, if toxicities warrant) = 12.5 mCi/m\^2 Dose Level 1 (beginning dose) = 15.6 mCi/m\^2 Dose Level 2 (escalation dose) = 18.75 mCi/m\^2 Dose escalation will proceed with no limiting toxicities at each level (maximum of 8 participants at each dose level). With maximum tolerated dose confirmed, an expansion phase will proceed. |
| Pediatric High-Grade Glioma Patients | EXPERIMENTAL | 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. |
| CLR 131 | EXPERIMENTAL | CLR 131 intravenous administration |
| Name | Type | Description |
|---|---|---|
| CLR 131 | DRUG | CLR 131 is a radiopharmaceutical dosed intravenously over a period of approximately 30 minutes, dose will be based on total body surface area calculated from actual body weight and height |
Inclusion Criteria: * Participant must be informed of the investigational nature of the study and must be able to sign a written informed consent. * Participants with histologically or cytologically confirmed solid malignancy that has recurred in the head and neck (above the clavicles) region, e.g....
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CLR 131 is an investigational small molecule being studied for use in oncology, specifically for high-grade glioma, head and neck cancer, and pediatric solid tumors. It is currently in Phase 1 clinical trials for these indications.
CLR 131 is a radiotherapeutic small molecule that delivers radiation directly to cancer cells. It is designed to target and destroy malignant cells while sparing healthy tissue, though the specific molecular target has not been disclosed.
CLR 131 is being developed by Cellectar Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLRB. The company is conducting Phase 1 clinical trials for this investigational drug.
CLR 131 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All ongoing and completed studies are early-stage trials focused on safety and dosing.
CLR 131 is being studied in three Phase 1 trials. NCT03478462 is a dose escalation study in pediatric patients with relapsed or refractory malignant tumors. NCT04105543 combines CLR 131 with radiation for head and neck cancer. NCT05610891 evaluates CLR 131 in pediatric patients with inoperable relapsed or refractory high-grade glioma.
Yes, CLR 131 is being studied in pediatric patients. Two of its Phase 1 trials focus on children: NCT03478462 enrolls patients aged 2 years and older with solid tumors, and NCT05610891 enrolls patients aged 10 years and older with high-grade glioma.