Participate in a Leptomeningeal Metastases Clinical Trial

Now Recruiting Patients with LM


Trial Information

Leptomeningeal Metastases (LM) is sometimes referred to as leptomeningeal cancer, leptomeningeal disease, neoplastic meningitis, or meningeal carcinomatosis. This rare but serious condition happens when cancer cells spread to the membranes surrounding the brain and spinal cord.  Leptomeningeal Metastases is most commonly found in patients with melanoma, breast, lung, or gastrointestinal cancer. Unfortunately, there are no FDA approved treatments specifically for Leptomeningeal Metastases.

Plus Therapeutics is developing a new targeted radiation therapy, Rhenium (186Re) Obisbemeda, for central nervous system cancers such as Leptomeningeal Metastases.  In the U.S. ReSPECT-LM clinical trial, doctors will give Leptomeningeal Metastases patients a single dose of Rhenium (186Re) Obisbemeda through a small catheter placed under the patient’s scalp. This drug will be administered in less than 5 minutes in a hospital setting and the patient will go home the same day.

The ReSPECT-LM clinical trial is funded, in part, by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas, the second largest public funding source for cancer research in the world.

View Trial on ClinicalTrials.gov

View the ReSPECT-LM Trial Guide for Patients

NATIONAL TRIAL REFERENCE NUMBER

NCT05034497

When speaking with your physician, please have the national trial reference number available.

Patients Treated to Date

Single Group

  • All patients who enroll in the trial will receive medication while on the study.
  • All patients will receive a single dose of Rhenium (186Re) Obisbemeda.

Phase 1

  • A Phase 1 study is the first step in testing a new treatment in humans. A phase I clinical trial tests the safety, side effects, best dose, and timing of a new treatment. It may also test how the treatment affects the body. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Phase I clinical trials usually include only a small number of patients who have not been helped by other treatments.

Progress

  • Actual Study Start:  December 6, 2021
  • Estimated Primary Completion:  December 21, 2025 (the date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected)
  • Estimated Study Completion:  June 30, 2026 (the date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events, that is, the last participant's last visit). 

Plus Therapeutics is evaluating rhenium (186Re) obisbemeda, a novel radiotherapy for patients with Leptomeningeal Metastases in a Phase 1 clinical trial.

Watch now to learn more.

Patient Eligibility

Only a qualified healthcare professional can determine whether or not you are eligible to participate in a clinical trial. However, this information may be beneficial in initiating a conversation with your physician.  Patient reimbursement of up to $599 for time and travel is available.

Age Range

Adults, 18 years and older

Condition

Leptomeningeal Metastases from any solid tumor cancers (i.e. breast, lung, melanoma, gastrointestinal)

Prior Treatment

No prior whole brain or spinal cord radiation therapy

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Informed Consent

Able to understand the study purposes and risks

Gender

All; Women have negative pregnancy test at screening; Subjects must use effective contraception during study

Additional eligibility criteria may be found on ClinicalTrials.gov

Principal Investigators

There is a physician who is responsible for the scientific and technical direction of the clinical trial at each location.

Andrew Brenner, M.D., Ph.D.

UT Health San Antonio, Mays Cancer Center
Texas

Michael Youssef, M.D.

UT Southwestern Medical Center
Texas

Priya Kumthekar, M.D.

Northwestern Memorial Hospital
Illinois

Michael Schulder, M.D.

North Shore University Hospital
New York

Trial Locations

Please visit this website regularly for updates as new locations are added.

UT Health Science Center

San Antonio

North Shore University Hospital

New York

UT Southwestern Medical Center

Dallas

Northwestern Memorial Hospital

Chicago

What Can You Do Next?

Participating in a clinical trial is an important decision. If you believe this clinical trial might be a good fit and are interested in participating, please take the next step to see if you are eligible.

Discuss With Your Physician

Anyone participating in a clinical trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll.  If you are interested in participating in a clinical trial, please talk to your physician first.

Print Friendly, PDF & Email

Print, save, or email this page to your physician to discuss at your next visit.

Be sure to have National Trial Reference Number NCT05034497 available.

View the ReSPECT-LM Trial Guide for Patients

Contact A Trial Coordinator

A trial coordinator is a specialized researcher who supports the management and coordination of clinical research studies.  If you are interested in participating in a clinical trial, you may call a trial coordinator directly at one of the trial locations below.

UT Health Science Center
San Antonio

Leticia Velten
210-450-1921
velten@uthscsa.edu

North Shore University Hospital
Manhasset

Betsy Moclair
516-253-7753
bmoclair@northwell.edu

UT Southwestern Medical Center
Dallas

Tammy Rickfels
469-852-0719 or 214-645-2148
tammy.ricklefs@utsouthwestern.edu

Northwestern Memorial Hospital
Chicago

Laura Sharp
312-926-5115
laura.sharp@northwestern.edu

Contact Us


News

May 9, 2024

Plus Therapeutics Provides Highlights Regarding Leptomeningeal Metastases Acquisition and Topline Clinical Trial Data on the FORESEE Trial

April 22, 2024

Plus Therapeutics Receives $3 Million Award Recommendation from the United States Department of Defense

April 9, 2024

Neuro-Oncologist Andrew Brenner, M.D., Ph.D. and Barbara Blouw, Ph.D. Join Plus’ Management Team

March 27, 2024

Plus Therapeutics to Present at the National Comprehensive Cancer Network Annual Conference

March 25, 2024

Plus Therapeutics Announces Validation & Clinical Implementation of CSF-01 Leptomeningeal Cancer Cell Diagnostic

March 11, 2024

Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases

December 12, 2023

Plus Therapeutics Partners With K2bio for Development of Novel Tests for Cerebrospinal Fluid (CSF) Tumor Cell and Molecular Biomarker Analyses

November 29, 2023

Plus Therapeutics to Present at the 5th Targeted Radiopharmaceuticals Summit Europe

  • Presentation titled “Re-186 Radiolabelled NanoLiposomes for Rare Brain and Spinal Cord Tumors”

November 3, 2023

Plus Therapeutics Granted U.S. FDA Orphan Drug Designation to Rhenium (186Re) Obisbemeda for the Treatment of Breast Cancer with Leptomeningeal Metastases

October 10, 2023

Plus Therapeutics Completes Dosing in Cohort 4 of ReSPECT-LM Phase 1 Clinical Trial of Rhenium (¹⁸⁶Re) Obisbemeda in Leptomeningeal Metastases

  • Cohort 4 of the ReSPECT-LM Phase 1 dose escalation trial is the first of 4 planned cohorts in Part B; the Company anticipates moving into Cohort 5 following standard safety review

September 11, 2023

Plus Therapeutics Receives $1.9 Million Advance Payment from CPRIT and Plans to Present at the CPRIT Innovations in Cancer Prevention and Research Conference

September 5, 2023

Plus Therapeutics Initiates Part B of ReSPECT-LM Phase 1/2a Trial for Leptomeningeal Metastases

  • Plus Therapeutics announced treatment of the first patient in Part B (Cohort 4) of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.

August 11, 2023

Plus Therapeutics Reports ReSPECT-LM Phase 1 Trial Data at the 2023 SNO/ASCO CNS Cancer Conference

  • Dose escalation trial demonstrates preliminary safety and efficacy results including median overall survival of 10 months for patients with leptomeningeal metastases. FDA approves continuation to Phase 1 Part B of the ReSPECT-LM clinical trial.

June 29, 2023

Plus Therapeutics Reports Positive Interim Updates from Two ReSPECT™ Clinical Trials at SNMMI Annual Meeting

  • ReSPECT-LM Phase 1/Part A leptomeningeal metastases trial demonstrates safety and high absorbed radiation doses to the cerebrospinal fluid and leptomeninges

 

Publications

Posters

Brenner, Andrew et al. “Update Report of the ReSPECT Trials: Treatment of Recurrent Glioblastoma and Leptomeningeal Metastases with Rhenium (186Re) Obisbemeda.” NMN Precision Medicine Symposium 2024. 

Brenner, Andrew et al. “Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases Phase 1 Dose Escalation Trial: Update of Initial Safety and Feasibility.” NCCN Annual 2024. 

Brenner, Andrew et al. “Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases Phase 1 Dose Escalation Trial: Initial Safety and Feasibility.” SNO Annual Meeting 2023. 

Brenner, Andrew et al. “Phase 1A of the ReSPECT-LM Trial: Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM).” Cancer Prevention & Research Institute of Texas (CPRIT) Innovations 2023.

Brenner, Andrew et al. “Preliminary Clinical Data in the Phase 1/2a Dose Escalation Trial of Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial.” SNO/ASCO CNS Cancer Conference 2023.

LaFrance, Norman et al. “Preclinical and Preliminary Clinical Data in the Phase 1/2a Dose Escalation Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Leptomeningeal Metastases (LM): The ReSPECTTM-LM Trial.” SNMMI Annual Meeting 2023.

Presentations

Phase 1A of the ReSPECT-LM Trial: Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM), Cancer Prevention & Research Institute of Texas (CPRIT) Innovations Conference, October 3, 2023

KOL Roundtable on Leptomeningeal Metastases: An Obvious Disease Target for Radiotherapeutic Intervention,  SNO/ASCO CNS Cancer Conference, August 11, 2023

Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma: the ReSPECT™ Phase 1/2a Trial, EANM Congress, October 19, 2022

Resources

Updates

LM Diagnostic Assay

“Leptomeningeal metastases (LM) is significantly underdiagnosed because current tests such as MRI and cytology lack sensitivity,” said Priya U. Kumthekar, M.D., Associate Professor of Neurology (Neuro-oncology) and Medicine (Hematology and Oncology) at Northwestern...

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AANS Follow-Up

Thank you to everyone who stopped by our booth at the AANS annual meeting to learn more about our ReSPECT Recurrent Glioblastoma and Leptomeningeal Metastases clinical trials! If you missed us and would like more information, you can send us an email at...

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LM Acquistition Meeting

Plus Therapeutics provided highlights regarding Leptomeningeal Metastases acquisition and topline clinical trial data on the FORESEE Trial on this morning's investor call. Listen to the Replay: https://edge.media-server.com/mmc/p/nor9kmxs/ Highlights:...

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Reminder: AANS 2024

Reminder to come stop by the Plus Therapeutics booth #1057 at the American Association of Neurological Surgeons (AANS) annual conference this weekend in Chicago! Our team will be in the exhibit hall during the entire conference, so come say hello 👋...

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