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.
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)
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
Michael Youssef, M.D.
UT Southwestern Medical Center
Priya Kumthekar, M.D.
Northwestern Memorial Hospital
Trial Locations
Please visit this website regularly for updates as new locations are added.
UT Health Science Center
San Antonio
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, save, or email this page to your physician to discuss at your next visit.
Be sure to have National Trial Reference Number NCT05034497 available.
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
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
March 27, 2024
Plus Therapeutics to Present at the National Comprehensive Cancer Network Annual Conference
March 25, 2024
March 11, 2024
December 12, 2023
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
October 10, 2023
- 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
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
- ReSPECT-LM Phase 1/Part A leptomeningeal metastases trial demonstrates safety and high absorbed radiation doses to the cerebrospinal fluid and leptomeninges
April 18, 2023
- The Company plans to meet with U.S. FDA to discuss next steps for the Phase 1/Part B trial in the third quarter of 2023. Plus Therapeutics also expanded the number of active clinical trial sites by adding Northwestern Memorial Hospital, a world-class medical center and leader in clinical research, and the Company’s first site outside of Texas
Publications
Posters
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
Note: all external links
- American Brain Tumor Association
- American Cancer Society
- Brain Tumor Network
- Dictionary of Cancer Terms
- End Brain Cancer Initiative
- MedlinePlus (NIH)
- National Brain Tumor Society
- National Cancer Institute
- National Comprehensive Cancer Network
- Support Groups Listing
- The Brain Tumour Charity
- Trial Connect
- VirtualTrials.com
- Voices Against Brain Cancer
Updates
Welcome Dr. Brenner!
#ICYMI: Plus Therapeutics added Dr. Andrew Brenner to our management team. Dr. Brenner will provide substantial input on the Company’s central nervous system cancer development programs while continuing to maintain his academic practice and laboratory. Full Press...
LBBC Curtain Raiser
📣 Mark Your Calendars! Plus Therapeutics will be exhibiting at the @livingbeyondbc Thriving Together Metastatic Breast Cancer Conference, April 19-21. Come learn about our ReSPECT-LM clinical trial for Leptomeningeal Metastases and meet some of our team. Event...
PSTV Analysis
#ICYMI : "Plus Therapeutics (PSTV), the Healthcare sector company, was revisited by a Wall Street analyst...Analyst Justin Walsh from JonesTrading maintained a Buy rating on the stock and has a $32.00 price target. Justin Walsh has given his Buy rating due to a...
Welcome Brenner and Blouw
We would like to officially welcome Neuro-Oncologist Andrew Brenner, M.D., Ph.D. and Barbara Blouw, Ph.D. to the Plus Therapeutics Management Team! “As we prepare for the future, Plus is substantially strengthening its management in key areas such as cancer biology,...
