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OncoMatch/Clinical Trials/NCT07098806

Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases

Is NCT07098806 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies 186RNL for leptomeningeal metastasis.

Phase 1RecruitingPlus TherapeuticsNCT07098806Data as of Jun 2026

Treatment: 186RNLThis 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.

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Extracted eligibility criteria

Treatments studied

Other

186RNL

Disease stage

Metastatic disease required

Performance status

KARNOFSKY 70–100

Prior therapy

Cannot have received: intrathecal therapy

Exception: Prior intrathecal therapy allowed if given ≥14 days before study registration

Intrathecal therapy given less than 14 days before study registration

Cannot have received: intrathecal therapy

Concurrent intrathecal therapy

Cannot have received: systemically delivered therapy

Exception: Allowed if LM develops while on systemic therapy AND systemic therapy is NOT associated with more than grade 1 myelosuppression

Systemically delivered therapy UNLESS LM develops while on systemically delivered therapy AND the systemically delivered therapy is NOT associated with more than grade 1 myelosuppression

Cannot have received: systemically delivered therapy

Exception: Prior systemic therapy allowed if given ≥28 days before study registration

Systemically delivered therapy given less than 28 days before study registration

Cannot have received: whole brain radiation therapy

Exception: Prior spinal cord/cauda equina or partial brain/SRS allowed under specified dose/timing conditions

Patients who had any therapeutic radiation dose to the whole brain regardless of when the radiation treatment was delivered, except: Prior radiation dose to the spinal cord and/or cauda equina is allowed if the equivalent dose in 2 Gy fractions (EQD2) was ≤ 30 Gy to the spinal cord and/or cauda equina using α/β ratio of 3 and if prior radiotherapy has been > 14 days and ≤ 6 months, or was ≤45 Gy to the spinal cord and/or cauda equina using α/β ratio of 3 and if prior radiotherapy has been > 6 months. Prior stereotactic radiosurgery (SRS) to the brain or partial brain radiotherapy is allowed if the equivalent dose in 2 Gy fractions (EQD2) was ≤ 30 Gy to brainstem and/or optic structures (optic nerves, optic chiasm) using α/β ratio of 3 and if prior radiotherapy has been > 14 days and ≤ 6 months, or was ≤ 45 Gy to the brainstem and/or optic structures (optic nerves, optic chiasm) using α/β ratio of 3 and if prior radiotherapy has been > 6 months.

Lab requirements

Blood counts

ANC ≥ 1000/μL; Platelet count ≥ 75,000/μL; Hemoglobin ≥ 9.0 g/dL (without hematologic support)

Kidney function

Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault Equation)

Liver function

Bilirubin ≤ 1.5x ULN; AST/ALT ≤ 3.0x ULN for subjects with normal liver; AST/ALT ≤ 5.0x ULN for subjects with liver metastasis

Acceptable liver function: Bilirubin ≤ 1.5x ULN; AST/ALT ≤ 3.0x ULN for subjects with normal liver; AST/ALT ≤ 5.0x ULN for subjects with liver metastasis. Acceptable renal function: Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault Equation). Acceptable hematologic functioning (without hematologic support): ANC ≥ 1000/μL; Platelet count ≥ 75,000/μL; Hemoglobin ≥ 9.0 g/dL.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • The Cancer Therapy and Research Center at UTHSCSA · San Antonio, Texas

Showing up to 5 US sites.

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Frequently asked questions

Is NCT07098806 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior intrathecal therapy, intrathecal therapy, systemically delivered therapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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