Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rhenium-186 Nanoliposome · 1 trial · 2 indications
Determine the maximum tolerated dose (MTD) of 186RNL administered by convection-enhanced delivery (CED) in subjects with supratentorial recurrent, refractory, or progressive pediatric ependymoma or HGG.
Determine the best overall response rate (ORR) by Radiographic Assessment in Neuro-Oncology (RANO) criteria following 186RNL administration in subjects with supratentorial recurrent, refractory, or progressive pediatric ependymoma.
Determine progression-free survival at 12 months (PFS12) in subjects with supratentorial recurrent, refractory, or progressive pediatric HGG.
| Arm | Type | Description |
|---|---|---|
| Phase 1a - Cohort A | EXPERIMENTAL | Up to six subjects will be enrolled in Cohort A. Tumor size will be limited to a maximum diameter of (less than or equal to) ≤2 cm and a maximum volume of (less than or equal to) ≤4.2 mL. Up to two CED catheters will be utilized in Cohort A at the discretion and consensus of the PI, neurosurgeon, and/or study team. The concentration of 186RNL infusate in Cohort A is 0.5 mCi/mL, with a corresponding estimated absorbed dose of \~87.5Gy. |
| Phase 1a - Cohort B | EXPERIMENTAL | Up to six subjects will be enrolled in Cohort B. Tumor size will be limited to a maximum diameter of 3.5 cm in the longest axis and a maximum volume of 22.4 mL. Up to 5 total catheters may be used for Cohort B at the discretion and consensus of the PI, neurosurgeon, and/or study team to ensure total tumor volume coverage. The concentration of 186RNL infusate in Cohort B is 1.0 mCi/mL with a corresponding estimated absorbed dose of \~176Gy (\~2x Cohort A). |
| Phase 1b | EXPERIMENTAL | Phase 1b continued dosing escalation will be defined following review of the safety data from Phase 1a. |
| Phase 2 | EXPERIMENTAL | The Phase 2 expansion study will utilize the maximum tolerable dose (MFD) determined from the Phase 1 dose escalation study. If no maximal tolerable dose is found, tumors may be treated up to an estimated total absorbed dose of 176 Gy. Varying concentrations of 186RNL infusate (0.5-2.5 mCi/mL) may be used to achieve this maximum tolerable dose while maintaining total tumor volume coverage. Phase 2a will enroll an additional 12 patients with a diagnosis of recurrent, refractory, or progressive ependymoma and an additional 20 patients with a diagnosis of recurrent, refractory, or progressive HGG. |
| Name | Type | Description |
|---|---|---|
| Rhenium-186 Nanoliposome | DRUG | Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL), BMEDA-chelated-186rhenium encapsulated within liposomes, allows the 186Re to be directly delivered to the site of the tumor through CED and maintain localization at the site of infusion. |
Inclusion Criteria: 1. 6 years to 21 years\* of age. 2. Lesion number and size: 1. Phase 1a/b only: A single lesion (less than or equal to) ≤3.5 cm (longest axis) and volume of (less than or equal to) ≤22.4 mL as the largest tumor (subsequent to individual Cohort lesion size requirements). 2...
Rhenium-186 Nanoliposome is an investigational small molecule being studied for the treatment of ependymoma, a type of tumor that can occur in the brain or spine. It is also being evaluated in high-grade gliomas. The drug is currently in Phase 1 clinical development for these oncology indications.
Rhenium-186 Nanoliposome is a radiotherapeutic agent that delivers the radioisotope rhenium-186. It is designed to deliver targeted radiation to tumor sites, potentially damaging cancer cells while sparing surrounding healthy tissue. The specific molecular target is not disclosed in the available information.
Rhenium-186 Nanoliposome is being developed by PLUS THERAPEUTICS, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol PSTV. The drug is currently in Phase 1 clinical trials for the treatment of ependymoma and high-grade gliomas.
Rhenium-186 Nanoliposome is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to determine the maximum tolerated dose, safety, and tolerability of the drug in pediatric patients.
Rhenium-186 Nanoliposome is being studied in a Phase 1 clinical trial with the identifier NCT07061626. This trial is titled 'Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma.' The trial is not yet recruiting and has an estimated enrollment of 56 participants.
Rhenium-186 Nanoliposome is also referred to as 186Re in clinical trial documentation. The drug is a nanoliposomal formulation of the radioisotope rhenium-186, which is being investigated for its potential to deliver targeted radiation therapy to tumors in patients with ependymoma and high-grade gliomas.