NCT07098806 Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
| NCT ID | NCT07098806 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Plus Therapeutics |
| Condition | Leptomeningeal Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2026-10-02 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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 I or IIA-C). 4. Karnofsky performance status of 70 to 100. 5. Acceptable liver function: 1. Bilirubin ≤ 1.5 times the upper limit of normal. 2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal for subjects with normal liver. 3. AST (SGOT) and ALT (SGPT) ≤ 5.0 times the upper limit of normal for subjects with liver metastasis. 6. Acceptable renal function: a. Creatinine clearance greater than or equal to 60 mL/min (using the Cockcroft-Gault Equation). 7. Acceptable hematologic functioning (without hematologic support): 1. ANC ≥ 1000 cells μL. 2. Platelet count ≥ 75,000/μL. 3. Hemoglobin ≥ 9.0 g/dL. 8. All women of childbearing potential must have a negative serum pregnancy test