Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07098806 | Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases | PHASE1 | RECRUITING | 24 | — | — | Jul 2, 2025 | Oct 2, 2031 | Aug 1, 2025 | 1 | United States |
| NCT05034497 | Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases | PHASE1 | ACTIVE NOT_RECRUITING | 18 | — | — | Dec 6, 2021 | Jun 30, 2026 | Mar 26, 2025 | 6 | United States |
Evaluation of any toxicity associated with research treatment per Common Criteria for Adverse Events.
SPECT imaging of the radioactive materials spread in the Cerebrospinal Fluid.
Evaluation of any toxicity associated with research treatment as determined by National Cancer Institute (NCI) common Terminology Criteria for adverse events (CTCAE).
Safety will be evaluated by the incidence of AEs and SAEs graded according CTCAE version 5.0.
Maximum Tolerated Dose (MTD) will be evaluated by testing increasing doses with 3 to 6 participants in each cohort. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants.
| Arm | Type | Description |
|---|---|---|
| Experimental: Multiple Doses | EXPERIMENTAL | This is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) administered via intraventricular catheter for any primary solid tumor cancer with leptomeningeal metastases to identify an MTD/MFD for a given dose, interval duration, and number of doses. |
| Dose Escalation | EXPERIMENTAL | Each participant will receive a single 5cc administration of 186RNL. At each dose level, a minimum of three to a maximum of six participants will be enrolled. If no dose limiting toxicity is observed in the initial three participants, then the next higher dose level cohort will open for enrollment. The dose escalation scheme will follow a modified Fibonacci dose escalation scheme. |
| Name | Type | Description |
|---|---|---|
| 186RNL | DRUG | Multiple Doses of 186RNL |
Inclusion Criteria: 1. At least 18 years of age. 2. Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB. 3. Documented LM from any primary solid tumor cancer per EANO-ESMO Clinical Practice Guidelines (Types ...