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RMC-5552 Monotherapy in Adult Subjects with Recurrent Glioblastoma
This phase I/Ib trial tests the side effects, best dose, tolerability, and effectiveness of RMC-5552 in treating patients with glioblastoma that has come back (recurrent). RMC-5552 is a type of medicine called an mechanistic target of rapamycin (mTOR) inhibitor. These types of drugs prevent the formation of a specific group of proteins called mTOR. This protein controls cancer cell growth, and the study doctors believe stopping mTOR from forming may help to kill tumor cells.
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RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)
This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma.
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Role of Repeat Resection in Recurrent Glioblastoma
Patients with recurrent Glioblastoma (GBM) are commonly presented to surgeons, along with the question of whether or not to re-resect the recurrence. There is no Level 1 evidence to support a role for repeat surgery in this context, but a multitude of observational research suggests that repeat surgery may improve quality survival. Unfortunately, these studies all suffer from selection bias. The goal of this study is to provide a care trial context to help neurosurgeons manage patients presenting with recurrent GBM, with no additional risks, tests, or interventions than what they would normally encounter in routine care. Secondary goals include a test of the hypothesis that...
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Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy.
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Sacituzumab Govitecan in Recurrent Glioblastoma
This is an open-label single arm study. All patients will receive the investigational agent.
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Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma
The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed glioblastoma. The study will be conducted in three consecutive parts: a dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.
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Safety and Efficacy of NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain. The study will have three phases, Phase 1, Phase 2a and Phase 2b.
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Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients
The goal of this clinical trial is to learn if NRG103 works to treat recurrent GBM in adults. It will also learn about the safety of NRG103. The main questions it aims to answer are: Does NRG103 prolong overall survival or disease-free survival in patients with GBM? What medical problems do participants have when receiving NRG103 treatment? Researchers will give patients with NRG103 to see if NRG103 works to treat recurrent GBM. Participants will: Receive NRG103 twice in 14 days Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms
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Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas
This is a single-center, open-label, multi-dose phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of ZSNeo-DC1.1, a personalized dendritic cell injection, in subjects with recurrent or progressive WHO grade III-IV gliomas post-standard treatment. The subjects are adult GBM patients who have undergone surgical resection for recurrence. After the completion of reoperation, subjects will receive autologous DC vaccine treatments as scheduled. The autologous genetic-modification-free DC cells will be loaded with multiple tumor neoantigen peptides and administered (i.h) to subjects. After 3 injections, the investigator will review subject's tolerance...
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Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
This multi-site, Phase 1/2a clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with radiographically-confirmed progression of Grade IV glioma or recurrent primary or secondary Grade IV glioma. The study will have two phases, Phase 1 and Phase 2a. Phase 1 is a standard cohort dose escalation 3+3 design used to determine the maximum tolerated dose for Phase 2a. There will be up to 24 patients enrolled in Phase 1. There will be 25 patients enrolled in Phase 2a. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day...
