Participate in a Brain Cancer Clinical Trial

Now Recruiting Patients with Recurrent Glioblastoma (GBM)


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.

View Trial on ClinicalTrials.gov

View ReSPECT-GBM Clinical Trial Guide for Patients

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

11

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

Age Range

Adults, 18 Years and Older

gender

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 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 NCT01906385 available.

View the ReSPECT-GBM Clinical Trial Guide PDF

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

San Antonio, Texas

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

UT Southwestern

Dallas, Texas

Briana Carter
214-645-2148
Briana.carter@UTSouthwestern.edu

MD Anderson

Houston, Texas

Ji Xiaorong
713-745-4243
xji@mdanderson.org

Contact Us


News

April 22, 2023

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

April 9, 2023

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

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 20, 2023

Plus Therapeutics Reports New Interim ReSPECT-GBM Phase 2 Trial Data at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar

  • 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

Plus Therapeutics to Host Virtual KOL Event on New Phase 2 ReSPECT-GBM Data in Recurrent Glioblastoma Presented at the Society for NeuroOncology (SNO) Conference on Monday, November 20, 2023

October 25, 2023

Plus Therapeutics to Present at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar

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

  • 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 Announces First Patient Dosed in ReSPECT-GBM Phase 2b Trial of Rhenium (186Re) Obisbemeda for Treatment of Recurrent Glioblastoma

  • 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

Brenner, Andrew et al.  “Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma:  The ReSPECT Phase 1 Trial.”  Neuro-Oncology, Volume 23, Issue Supplement_6, November 2021, Pages vi65-vi66.

Brenner, Andrew et al.  “High Absorbed Doses of Rhenium-186 NanoLiposomes (RNL) in Recurrent GBM:  A Phase 1 Study.”  Neuro-Oncology, Volume 22, Issue Supplement_2, November 2020, Page ii186.

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 Recurrent Glioblastoma via Convection Enhanced Delivery: A Report on Phase 2.” SNO Annual Meeting 2023.

Brenner, Andrew et al. “Update Report of the ReSPECT-GBM Phase 1 Dose Escalation Trial of Rhenium (186Re) Obisbemeda (186RNL) in Recurrent Glioma via Convection Enhanced Delivery.” SNO Annual Meeting 2023.

Brenner, Andrew et al. “Safety and Feasibility Results from a Phase 1/2 Clinical Trial of Rhenium (186Re) Obisbemeda (186RNL) in Recurrent Glioma: The ReSPECT-GBM Trial.” SNO/ASCO CNS Cancer Conference 2023.

LaFrance, Norman et al.  “Safety and Feasibility of (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL) in Recurrent Glioma: The ReSPECTTM-GBM Phase 1/2 Trial.”  SNMMI 2023 Annual Meeting.

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.

Floyd, John et al.  “Image-Guided Rhenium-186 NanoLiposome (186RNL) Brachytherapy in the Treatment of Recurrent Glioblastoma:  Technique, Image Analysis, Dosimetry, and Monitoring.”  2021 ASTRO Annual Meeting.

Brenner, Andrew et al.  “Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma:  the ReSPECT Phase 1 Trial.”  E-Poster, 2021 American Society of Clinical Oncology Annual Meeting, June 4-8, 2021.

Brenner, Andrew et al.  “Safety and Feasibility of Rhenium-186 NanoLiposomes (RNL) in Recurrent GBM:  the ReSPECT Phase 1 Trial.”  E-Poster, 2020 Society for Neuro-Oncology Annual Meeting, November 19-21, 2020.

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

Updates

Active Award Support for ReSPECT

"Plus Therapeutics' commitment to revolutionizing cancer treatment extends beyond this latest award. With $23 million in active awards support, the company is at the forefront of targeted radiotherapeutic research. Moreover, ongoing trials, including ReSPECT-GBM for...

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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:...

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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...

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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...

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