Leptomeningeal MetastasisPhase 1/2CA2024-LM-001NCT07098806
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
A Phase 1/2 study testing 186RNL in people with Leptomeningeal Metastasis, run by Cerenome at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis
- What is being tested?
- 186RNL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to 2 Oct 2031
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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:
- 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.
- Normal CSF flow and distribution by an accepted CSF flow study (e.g., 111Indium-DTPA or acceptable substitute) before first treatment with the study drug, based on study imaging interpretation and clinical correlation.
- Corticosteroids are permitted as clinically indicated.
Who cannot join
- 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.
- Prior AEs due to alopecia, anemia, neutropenia, and lymphopenia are not required to be recovered to Grade ≤1 prior to study registration, assuming other inclusion criteria are satisfied.
- Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir.)
- Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt.
- Females of childbearing potential who are pregnant, breastfeeding, or may possibly be pregnant, without a negative serum pregnancy test (see inclusion criteria).
- Serious intercurrent illnesses, which could interfere with the planned treatment schedule.
Show all 14Show fewer
- 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:
- Intrathecally delivered therapy: i. Concurrent: Concurrent intrathecal therapy. ii. Prior: Intrathecal therapy given less than 14 days before study registration.
- 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.
- Prior: Systemically delivered therapy given less than 28 days before study registration.
- Projected survival of less than 60 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229
Leti Velten, RN, 210-450-1921, velten@uthscsa.edu
Andrew Brenner, M.D.,Ph.D
About this study
Official title: A 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
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
- Being tested
- 186RNL
- 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
- Medical subject headings
- Meningeal Carcinomatosis, Neoplasms, Pathologic Processes, Meningeal Neoplasms, Central Nervous System Neoplasms, Nervous System Neoplasms, Neoplasms by Site, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
186RNLDrug
Multiple Doses of 186RNL
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 186RNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Evaluation of any toxicity associated with research treatment per Common Criteria for Adverse Events.
Measured: 13 months
Dose Distribution of 186RNL
SPECT imaging of the radioactive materials spread in the Cerebrospinal Fluid.
Measured: 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).
Measured: 13 months
Secondary outcomes (5)
Determine the objective response rate (ORR).
Determine the overall response rate (ORR) defined as the proportion of all evaluable participants achieving a response as the best overall response at the time of progression.
Measured: 13 months
Determine the overall survival (OS).
The time from first treatment to date of death.
Measured: 13 months
Characterize the dosimetry profile of 186RNL.
using the following equation to calculate the average radiation-absorbed dose in the CSF Volume (Eckerman and Endo 2008): D (Gy) = 7.126 (Gy.g/mCi.h) × A cummu. (mCi.h)/ m (g) D is the average radiation-absorbed dose in Gy. A cummu. is the cumulative radioactivity in mCi.h calculated as described above. m is the weight of the radioactivity distribution volume in grams.
Given that there is no specific tumor mass to use for organ mass in grams identifiable post-infusion, the Sponsor proposes to use the estimated total CSF volume to calculate the absorbed dose to the CSF.
To perform radiation-absorbed dose calculation, the weight will be calculated from the average CSF volume (Adult Male: 140 ml; Adult Female: 120 ml), assuming the density of 1 g/cm3.
Measured: 13 months
Determine neurologic progression-free survival (PFS).
The time from first treatment to progression.
Measured: 13 months
Evaluate Neurologic status by NANO scale
Neurologic Assessment in Neuro- Oncology (NANO) The NANO scale is a quantifiable evaluation of 9 relevant neurologic domains based on direct observation and testing conducted during routine office visits. The score defines overall response criteria. The scale scores nine domains: gait, strength, ataxia, sensibility, visual fields, facial paralysis, language, level of consciousness, and behavior. Each domain has a score between 0 and 2 or 3, with 0 indicating normal function and higher scores indicating increasing deficits.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start2 Jul 2025
- Primary completion2 Oct 2026 (estimated)
- Study completion2 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerenome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098806
- Sponsor's protocol ID
- CA-2024-LM-001
- Acronym
- CA2024-LM-001
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No