Trial Information
The purpose of the ReSPECT-GBM Clinical Trial is to assess the safety, tolerability, and distribution of a new medication, rhenium (186Re) obisbemeda, in adults with recurrent glioblastoma after standard surgical, radiation, and/or chemotherapy treatment. ReSPECT-GBM is supported by the U.S. National Institutes of Health / National Cancer Institute.
NATIONAL TRIAL REFERENCE NUMBER
NCT01906385
When speaking with your physician, please have the national trial reference number available.
Phase 1 Patients Treated to Date
28
Phase 2 Patients Treated to Date
10
Single Group
- All patients who enroll in the trial will receive medication while on the study.
- All patients will receive a single treatment of rhenium (186Re) obisbemeda.
Phase 1/2
- Phase 1: A Phase 1 study of a new medication is usually the first that involves human volunteers who have the disease or condition the investigational medicine is designed to treat. The primary objective of Phase 1 studies is to identify the highest dose of the new medication that can be safely given without serious side effects.
- Phase 2: If a new medication is found to be reasonably safe in a Phase 1 study, it can then be evaluated in a Phase 2 study to determine if it works. Doctors will assess whether the new medication provides a specific benefit or response, such as tumor shrinkage, improved quality of life, or longer patient survival.
Progress
- Actual Study Start: June 3, 2015
- Estimated Primary Completion: January 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: January 2025 (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 brain cancer patients, in the U.S. NIH-supported ReSPECT-GBM Phase 2 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. Healthy volunteers are not needed.
Condition
Recurrent Glioblastoma
Age Range
Adults, 18 Years and Older
Gender
All
Imaging
Able to undergo a MRI scan
Prior Medication
Have not taken Avastin (bevacizumab)
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
Toral Patel, M.D.
UT Southwestern Medical Center
Peter O’Donnell Jr. Brain Institute
Jeffrey Weinberg, M.D.
UT MD Anderson Cancer Center
Anne C. Brooks Brain & Spine Center
Trial Locations
There are currently 3 clinical trial locations in the United States that are actively screening and enrolling patients.
Please visit this website regularly for updates as new locations are added.
UT Health
San Antonio, Texas
UT Southwestern
Dallas, Texas
MD Anderson
Houston, Texas
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 NCT01906385 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.
Contact Us
News
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 20, 2023
- Median overall survival (mOS) in 15 patients with recurrent glioblastoma (rGBM) from the Phase 2 study is 13 months, which is 63% better than current standard of care (bevacizumab monotherapy) of 8 months; 9 of the 15 patients remain alive
- Median progression free survival (mPFS) is 11 months, compared to SOC at 4 months
- Rhenium (186Re) Obisbemeda continues to demonstrate a favorable safety profile, despite delivering up to 20x the dose of radiation (up to 740 Gy) typically delivered by external beam radiation therapy (EBRT) for rGBM patients (up to 35 Gy)
- Imaging data presented by Andrew Brenner, MD, PhD is consistent with the efficacy signal of Rhenium (186Re) Obisbemeda in rGBM
November 15, 2023
October 25, 2023
- Presentation titled: Multi-parametric MRI and SPECT Assessment of Treatment Dose and Efficacy in Respect-GBM for recurrent glioblastoma (rGBM)
July 27, 2023
Plus Therapeutics to Present at the 2023 SNO/ASCO CNS Cancer Conference
- Presentations titled: [LMAP-21] Preliminary Clinical Data in the Phase 1/2a Dose Escalation Trial of Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial; [TIPS-23] Safety and Feasibility Results from a Phase 1/2 Clinical Trial of Rhenium (186Re) Obisbemeda (186RNL) in Recurrent Glioma: The ReSPECT-GBM Trial; [TIPS-22] A two-part, Phase 1 study of Rhenium (186Re) Obisbemeda (186RNL) delivered by convection enhanced delivery (CED) for recurrent, refractory, or progressive childhood ependymoma and high-grade glioma (HGG)
July 13, 2023
Plus Therapeutics to Present at the 2nd Annual Targeted Radiopharmaceuticals Summit
- Presentations titled: Re-186 Radiolabelled NanoLiposomes for Rare Brain & Spinal Cord Tumors, and Novel Approaches to Central Nervous System Targeted Radiotherapeutics
June 29, 2023
- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today reported positive interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM) at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023 in Chicago, Illinois.
January 18, 2023
- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the first patient has been dosed in the ReSPECT-GBM Phase 2b dose expansion clinical trial evaluating rhenium (186Re) obisbemeda for the treatment of recurrent glioblastoma (GBM).
Publications
Abstracts
Posters
Brenner, Andrew et al. “Safety & Feasibility of Rhenium-186 Nanoliposomes (186RNL) in Recurrent Glioma: the ReSPECT Phase 1 Trial.” 2022 Annual Conference on CNS Clinical Trials & Brain Metastases.
Presentations
KOL Event on New Phase 2 ReSPECT-GBM Data in Recurrent Glioblastoma Presented at the Society for NeuroOncology (SNO) Conference, SNO Annual Meeting 2023, November 20, 2023.
ReSPECT-GBM Clinical Trial Update, SNMMI 2023 Annual Meeting, June 26, 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
Head for the Cure: North Texas
Join some of the Plus Therapeutics team at the Head for the Cure 5K - North Texas on May 4th! They will be out supporting the local community, cancer research, and "Defeating Brain Cancer Step by Step." We hope to see you there 🏃🏃♂️🏃♀️ Event information:...
NMN Curtain Raiser
Join us at NMN Symposium: Diagnostic and Therapeutic Innovations in the Era of Precision Medicine – Nuclear Medicine Meets Neuro-Oncology, being held April 26-27, in Vienna, Austria as Plus Therapeutics takes the stage. Presentation by Andrew Brenner, M.D., Ph.D....
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...
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...