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

NCT07098806 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CA-2024-LM-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Leptomeningeal Metastasis

Keywords

Neoplastic Processes Neoplasms; Neoplasms; Pathologic Processes; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neoplasm Metastasis; Meningeal Carcinomatosis

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose

  Evaluation of any toxicity associated with research treatment per Common Criteria for Adverse Events.

  13 months

• Dose Distribution of 186RNL

  SPECT imaging of the radioactive materials spread in the Cerebrospinal Fluid.

  13 months

• Safety and tolerability of multiple dose treatment

  Evaluation of any toxicity associated with research treatment as determined by National Cancer Institute (NCI) common Terminology Criteria for adverse events (CTCAE).

  13 months

Secondary Outcomes (5)

• Determine the objective response rate (ORR).

  13 months

• Determine the overall survival (OS).

  13 months

• Characterize the dosimetry profile of 186RNL.

  13 months

• Determine neurologic progression-free survival (PFS).

  13 months

• Evaluate Neurologic status by NANO scale

  13 months

Other Outcomes (4)

• Exploratory: Assess response using CSF tumor cell enumeration and compare to standard of care cytology.

  13 months

• Exploratory: Assess response using pharmacodynamic (PD) markers.

  13 months

• Safety: Determination of the incidence and severity of adverse events (AE) and serious adverse events (SAE).

  13 months

Study Arms (1)

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.

Drug: 186RNL

Interventions

186RNL DRUG

Multiple Doses of 186RNL

Experimental: Multiple Doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.
• Documented LM from any primary solid tumor cancer per EANO-ESMO Clinical Practice Guidelines (Types I or IIA-C).
• Karnofsky performance status of 70 to 100.
• Acceptable liver function:
• Bilirubin ≤ 1.5 times the upper limit of normal.
• AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal for subjects with normal liver.
• AST (SGOT) and ALT (SGPT) ≤ 5.0 times the upper limit of normal for subjects with liver metastasis.
• Acceptable renal function:
• a. Creatinine clearance greater than or equal to 60 mL/min (using the Cockcroft-Gault Equation).
• Acceptable hematologic functioning (without hematologic support):
• ANC ≥ 1000 cells μL.
• Platelet count ≥ 75,000/μL.
• Hemoglobin ≥ 9.0 g/dL.
• All women of childbearing potential must have a negative serum pregnancy test at screening. Male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose.

You may not qualify if:

• The subject has not recovered to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study, at time of study registration.
• Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir.)
• Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt.
• Serious intercurrent illnesses, which could interfere with the planned treatment schedule.
• 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.
• Prior or concurrent therapy:
• a. Intrathecally delivered therapy: i. Concurrent: Concurrent intrathecal therapy. ii. Prior: Intrathecal therapy given less than 14 days before study registration.
• b. Systemically delivered therapy: i. Concurrent: 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.
• ii. Prior: Systemically delivered therapy given less than 28 days before study registration.
• Projected survival of less than 60 days.

Sponsors & Collaborators

• Plus Therapeutics: lead

Study Sites (1)

The Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Meningeal Carcinomatosis; Neoplasms; Pathologic Processes; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Central Study Contacts

Rachael Hershey

CONTACT

1(210)791-8723; patients@respect-trials.com

Andrew Brenner, M.D.,Ph.D

CONTACT

1(210)791-8723; patients@respect-trials.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 1, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): October 2, 2026
• Study Completion (Estimated): October 2, 2031
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)