Leptomeningeal MetastasisPhase 1ReSPECT-LMNCT05034497
Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
A Phase 1 study testing 186RNL in people with Leptomeningeal Metastasis, run by Cerenome at 6 sites in United States.
Trial summary
This is an open-label Phase I clinical study that will administer a single dose of 186RNL via intraventricular catheter for treatment of Leptomeningeal Metastases (LM). 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
- 37 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Dec 2021to 19 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 at time of screening.
- Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.
- Subject has proven and documented LM that meets the requirements for the study:
- Current EANO-ESMO Clinical Practice Guidelines Type 1 and 2 LM of any primary type. 2D is excluded.
- Karnofsky performance status of 60 to 100.
- Acceptable liver function:
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- Bilirubin 1.5 times upper limit of normal
- AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal for subjects with normal liver
- AST (SGOT) and ALT (SGPT) ≤ 5.0 times upper limit of normal for subjects with liver metastasis
- Acceptable renal function with serum creatinine ≤ 2 times upper limit of normal
- Acceptable hematologic status (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.
- Subjects with a creatinine clearance greater than or equal to 60 mL/min (using the Cockcroft-Gault Equation) for males and females.
Who cannot join
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade ≤ 1 from AEs due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study. Prior AEs due to alopecia, anemia, and lymphopenia are not required to be recovered to Grade ≤ 1 prior to 186RNL treatment, assuming other inclusion criteria are satisfied.
- Obstructive or symptomatic communicating hydrocephalus.
- Ventriculo-peritoneal or ventriculo-atrial shunts without programable valves or contraindications to placement of Ommaya reservoir.
- Females of childbearing potential who are pregnant, breast feeding, or may possibly be pregnant without a negative serum pregnancy test (see inclusion criteria).
- Serious intercurrent illness, such as progressive systemic (extra leptomeningeal) disease, clinically significant cardiac arrhythmias, uncontrolled systemic infection, symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug, myocardial infarction, stroke, transient ischemic attack within 6 months, seizure disorder with any seizure occurring within 14 days prior to consenting or encephalopathy.
- Active severe non hematologic organ toxicity such as renal, cardiac, hepatic, pulmonary, or gastrointestinal systemic toxicity grade 3 or above.
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- Significant coagulation abnormalities such as inherited bleeding diathesis or acquired coagulopathy with unacceptable risks of bleeding.
- Patients who had any dose to the spinal cord or whole brain radiation therapy, regardless of when the radiation treatment was delivered. Prior, non-CNS radiation for primary tumor is allowed.
- Systemic chemotherapeutic agents with CNS penetration (such as temozolomide, carmustine, lomustine, capecitabine, carboplatin, vinorelbine, bevacizumab, irinotecan or topotecan) are excluded if given within 14 days or 5 half-lives, whichever is shorter, prior to 186RNL treatment.
- If the washout period is satisfied, the patient may be enrolled, providing all other I/E criteria are satisfied.
- If the patient is undergoing systemic chemotherapy with CNS penetration (such as temozolomide, carmustine, lomustine, capecitabine, carboplatin, vinorelbine, bevacizumab, irinotecan or topotecan) and they develop or have progressive/persistent LM while on the agent, they may be included in the trial at the PI's discretion.
- Systemic therapy (including investigational agents and small-molecule kinase inhibitors) is excluded if given within 14 days or 5 half-lives, whichever is shorter, prior to 186RNL treatment.
- If the washout period is satisfied, the patient may be enrolled, providing all other I/E criteria are satisfied.
- Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, are excluded if given within the above timepoints prior to 186RNL treatment.
- If the washout period is satisfied, the patient may be enrolled, providing all other I/E criteria are satisfied.
- Impaired CSF Flow Study, within 4 +/- 3 days of 186RNL treatment, based on study imaging and as determined by the investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northwestern Memorial Hospital Olson Pavilion
Chicago, Illinois, 60611
Ohio State University Hospital
Columbus, Ohio, 43201
Universiy of Texas Southwestern Medical Center
Dallas, Texas, 75390
Northshore University Hospital
Manhasset, New York, 11030
Lenox Hill Hospital
New York, New York, 10075
UT Health Science Center San Antonio / Mays Cancer Center
San Antonio, Texas, 78229
About this study
Official title: A Multicenter Phase 1 Clinical Study to Determine the Maximum Tolerated Dose/Maximum Feasible Dose, Safety,& Efficacy of Single Dose Rhenium-186 NanoLiposome (186RNL) Administered Via Intraventricular Catheter for Leptomeningeal Metastases
This is an open-label Phase I clinical study that will administer a single dose of 186RNL via intraventricular catheter for treatment of Leptomeningeal Metastases (LM).
Read the detailed description
This Phase I clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through an intraventricular catheter (Ommaya reservoir) in participants with Leptomeningeal Metastases (LM).
The clinical study treatment consists of a single administered 5cc dose of 186RNL per participant.
The clinical study will include the evaluation at separate dose levels. Three to six participants may be treated at each dose.
The maximum number of participants to be enrolled in the study is 27.
The clinical study treatment will be administered, following a CSF flow study, on an outpatient basis by the clinical study physician.
Participants will be followed for up to 12 months after the clinical study drug is administered.
The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.
- Conditions
- Leptomeningeal Metastasis
- Being tested
- 186RNL
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
186RNLDrug
Also called Rhenium-186 NanoLiposome
All participants will be required to have an Ommaya Reservoir and a CSF Flow Study.
Participants will receive a single 5cc dose of 186RNL via Ommaya Reservoir.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 186RNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Safety will be evaluated by the incidence of AEs and SAEs graded according CTCAE version 5.0.
Measured: 12 months
Incidence of dose-limiting toxicities (DLT)
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.
Measured: 12 months
Secondary outcomes (4)
Determination of the overall 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: 12 months
Determination of the duration of response (DoR)
Determine the duration of response (DoR) defined as the time from first response to LM progression.
Measured: 12 months
Determination of progression free survival (PFS)
Determine progression free survival (PFS) defined as the time from first treatment to date of LM progression or death from any cause.
Measured: 12 months
Overall survival (OS)
Determine the overall survival (OS) define as the time from first treatment to date of death.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start6 Dec 2021
- Primary completion19 Oct 2026
- Study completion19 Oct 2026
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerenome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Brenner, PhD, Principal investigator, The Cancer Therapy and Research Center at UTSHSCSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034497
- Sponsor's protocol ID
- 2021-LM-001
- Acronym
- ReSPECT-LM
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 1 Clinical Study to Determine the Maximum Tolerated Dose/Maximum Feasible Dose, Safety,& Efficacy of Single Dose Rhenium-186 NanoLiposome (186RNL) Administered Via Intraventricular Catheter for Leptomeningeal Metastases
- ClinicalTrials.gov ID
- NCT05034497
- Acronym / sponsor ID
- ReSPECT-LM / 2021-LM-001
- Conditions
- Leptomeningeal Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CerenomeIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 19 Oct 2026 (actual)
- Study completion
- 19 Oct 2026 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label Phase I clinical study that will administer a single dose of 186RNL via intraventricular catheter for treatment of Leptomeningeal Metastases (LM).
Detailed description
This Phase I clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through an intraventricular catheter (Ommaya reservoir) in participants with Leptomeningeal Metastases (LM).
The clinical study treatment consists of a single administered 5cc dose of 186RNL per participant.
The clinical study will include the evaluation at separate dose levels. Three to six participants may be treated at each dose.
The maximum number of participants to be enrolled in the study is 27.
The clinical study treatment will be administered, following a CSF flow study, on an outpatient basis by the clinical study physician.
Participants will be followed for up to 12 months after the clinical study drug is administered.
The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: 186RNLEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At least 18 years of age at time of screening.
- Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.
- Subject has proven and documented LM that meets the requirements for the study:
- Karnofsky performance status of 60 to 100.
- Acceptable liver function:
Key exclusion criteria (16 listed)
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade ≤ 1 from AEs due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study. Prior AEs due to alopecia, anemia, and lymphopenia are not required to be recovered to Grade ≤ 1 prior to 186RNL treatment, assuming other inclusion criteria are satisfied.
- Obstructive or symptomatic communicating hydrocephalus.
- Ventriculo-peritoneal or ventriculo-atrial shunts without programable valves or contraindications to placement of Ommaya reservoir.
- Females of childbearing potential who are pregnant, breast feeding, or may possibly be pregnant without a negative serum pregnancy test (see inclusion criteria).
- Serious intercurrent illness, such as progressive systemic (extra leptomeningeal) disease, clinically significant cardiac arrhythmias, uncontrolled systemic infection, symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug, myocardial infarction, stroke, transient ischemic attack within 6 months, seizure disorder with any seizure occurring within 14 days prior to consenting or encephalopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 186RNLAlso: Rhenium-186 NanoLiposomeAll participants will be required to have an Ommaya Reservoir and a CSF Flow Study. Participants will receive a single 5cc dose of 186RNL via Ommaya Reservoir. | Drug | Dose Escalation |
Primary outcome
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: 12 months
Safety will be evaluated by the incidence of AEs and SAEs graded according CTCAE version 5.0.
Incidence of dose-limiting toxicities (DLT)
Time frame: 12 months
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.
4 secondary outcomes
Determination of the overall response rate (ORR)
Time frame: 12 months
Determination of the duration of response (DoR)
Time frame: 12 months
Determination of progression free survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Brenner, PhD principal investigator
The Cancer Therapy and Research Center at UTSHSCSA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 186RNL in people with Leptomeningeal Metastasis, run by Cerenome at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AE) and serious adverse events (SAE) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.