Rhenium-186 NanoLiposome for Cancer

(CA2024-LM-001 Trial)

Overseen By Andrew Brenner, M.D.,Ph.D

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Plus Therapeutics

Must not be taking: Intrathecal therapy

Disqualifiers: Whole brain radiation, Serious illnesses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 13 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called Rhenium-186 NanoLiposome for individuals with solid tumor cancers that have spread to the lining of the brain and spinal cord. Researchers seek to determine the optimal dose and schedule for this treatment. The trial is open to those diagnosed with cancer that has spread to these areas and who are experiencing related symptoms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial does not clearly state if you must stop all current medications, but it does mention that you cannot have certain therapies close to the study start. Specifically, you cannot have had intrathecal therapy (medication delivered into the spinal fluid) within 14 days or systemic therapy (medication affecting the whole body) within 28 days before joining the study.

Is there any evidence suggesting that Rhenium-186 NanoLiposome is likely to be safe for humans?

Research has shown that rhenium-186 nanoliposome, a new treatment for cancer that has spread to the brain or spine, has been safe for patients so far. In one study, four adults received the treatment through a small tube in the brain, and it was well-tolerated, meaning patients did not experience severe side effects that would prevent them from continuing. Another analysis found that this treatment was safe and practical for patients with cancer that has spread to the coverings of the brain and spinal cord. Overall, these studies suggest the treatment is both feasible and safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Rhenium-186 NanoLiposome is unique because it uses a novel delivery method to target cancer cells in the brain. Unlike standard treatments that involve chemotherapy or radiation, which can affect the whole body, this treatment is administered directly into the brain's ventricular system using an intraventricular catheter. This localized approach allows for higher concentrations of the active ingredient, rhenium-186, to reach the cancer cells with potentially fewer side effects. Researchers are excited about this treatment because it offers a more direct, targeted attack on solid tumors with leptomeningeal metastases, which could improve effectiveness and reduce harm to healthy tissue.

What evidence suggests that Rhenium-186 NanoLiposome might be an effective treatment for cancer with leptomeningeal metastases?

Research has shown that a treatment called rhenium-186 nanoliposome (186RNL), which participants in this trial will receive, may help with leptomeningeal metastases, a serious cancer issue. Early results suggest that 186RNL is safe when administered directly into the brain's fluid areas, with no major side effects observed in initial trials. Studies also indicate that this treatment might extend the lives of patients with recurrent glioma, another challenging cancer. The treatment uses a radioactive particle to target and attack cancer cells in the brain. Overall, early evidence suggests it could be a beneficial option for some cancer patients. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with any primary solid tumor cancer that has spread to the lining of the brain and spinal cord (leptomeningeal metastases). Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have specific types or stages of cancer.

Inclusion Criteria

Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB

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 with their partner from entry into the study through 6 months after the last dose

My spinal fluid flow is normal as confirmed by a recent test.

Exclusion Criteria

Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt

I have recovered from side effects of previous cancer treatments to a mild level.

Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of rhenium (186Re) obisbemeda administered via intraventricular catheter to determine safety and efficacy

13 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rhenium-186 NanoLiposome

Trial Overview The study is testing multiple doses of a treatment called rhenium-186 nanoliposome (186RNL), given through an intraventricular catheter. It's an early-phase trial aiming to find the maximum tolerated dose for safety and effectiveness in treating leptomeningeal metastases from solid tumors.

How Is the Trial Designed?

Group I: Experimental: Multiple Doses Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Plus Therapeutics

Lead Sponsor

Trials

3

Recruited

110+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07098806

Study Details | NCT07098806 | Multiple Dose ... 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 ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/64/supplement_1/P978

Preliminary Clinical Data in The Phase 1/2a Dose Escalation ... A single treatment with 186 RNL delivered by an intraventricular catheter (Ommaya reservoir) in 4 adult patients is well tolerated, without dose limiting ...

3. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/PS14-01/753296/Abstract-PS14-01-Rhenium-186Re-obisbemeda-rhenium

Abstract PS14-01: Rhenium (186Re) obisbemeda (rhenium ... Background: Leptomeningeal metastases (LM) is a devastating systemic cancer complication most often seen with breast, lung, and melanoma ...

4. ir.plustherapeutics.com ir.plustherapeutics.com/news-releases/news-release-details/plus-therapeutics-advances-lead-drug-rhenium-186re-obisbemeda

Plus Therapeutics Advances Lead Drug Rhenium (186Re) ... The ReSPECT-LM single-dose escalation trial assessed the safety, tolerability, and potential efficacy of intrathecally administered Rhenium ( 186 Re) ...

5. cancernetwork.com cancernetwork.com/view/efficacy-seen-in-leptomeningeal-disease-with-rhenium-obisbemeda-therapy

Efficacy Seen in Leptomeningeal Disease With Rhenium ... Although results showed that rhenium obisbemeda improved survival and had no dose-limiting toxicities in recurrent glioma in the phase 1/2 ...

6. onclive.com onclive.com/view/rhenium-obisbemeda-demonstrates-safety-and-feasibility-in-leptomeningeal-metastases

Rhenium Obisbemeda Demonstrates Safety and Feasibility ... Rhenium obisbemeda proved feasible and safe for patients with leptomeningeal metastases in an interim analysis of the phase 1 ReSPECT-LM trial.

7. ir.plustherapeutics.com ir.plustherapeutics.com/news-releases/news-release-details/plus-therapeutics-presents-positive-respect-lm-phase-1-interim

Therapeutics Presents Positive ReSPECT-LM Phase 1 ... Single intrathecal dose of Rhenium ( 186 Re) Obisbemeda shows a favorable response rate and median overall survival in leptomeningeal metastases (LM) patients.