Clinical Trials for Brain Tumor

Phase I/II Study of Lutathera in Patients With Recurrent and/or Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Enrolling children to young adults (ages 4–39) with recurrent/progressive high-grade primary CNS tumors or meningiomas that are SSTR-positive on DOTATATE PET (Krenning ≥2). Participants receive 177Lu-DOTATATE (Lutathera), a somatostatin receptor 2–targeted peptide receptor radionuclide therapy delivering beta-emitting 177Lu, IV every 8 weeks for up to 4 cycles.

ClinicalTrials.gov ID: NCT05278208

Phase I Study of the Safety of Intracavitary Photodynamic Therapy (PDT) of the Brain Bordering Resected Recurrent Glioblastoma or Gliosarcoma Using Intravenous Photobac® and a Balloon Light Applicator

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with recurrent, surgically resectable glioblastoma or gliosarcoma after standard chemoradiation receive intravenous Photobac, a bacteriopurpurin-based photosensitizer designed to cross the BBB and preferentially accumulate in tumor, followed by fixed-dose 787 nm intracavitary light via a balloon applicator after resection. Dose-escalation evaluates safety/DLTs and MTD, with exploratory PK, tissue drug levels, and preliminary efficacy.

ClinicalTrials.gov ID: NCT05363826

Phase I/II Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with newly diagnosed, EGFR-overexpressing glioblastoma receive super-selective intra-arterial cetuximab after mannitol blood–brain barrier disruption at set postoperative intervals, in addition to standard Stupp chemoradiation. Cetuximab is an anti-EGFR IgG1 monoclonal antibody that blocks EGFR signaling and may mediate ADCC.

ClinicalTrials.gov ID: NCT02861898

Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab (Avastin) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with relapsed/refractory high-grade glioma (GBM, anaplastic astrocytoma/oligoastrocytoma), KPS ≥70, receive super-selective intraarterial bevacizumab 15 mg/kg after osmotic BBB disruption with IA mannitol, repeated at progression. One arm also adds standard biweekly IV bevacizumab 10 mg/kg between IA treatments; bevacizumab is an anti–VEGF-A monoclonal antibody inhibiting angiogenesis.

ClinicalTrials.gov ID: NCT01269853

Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with recurrent WHO grade IV glioblastoma planned for repeat resection and re-irradiation receive neoadjuvant pembrolizumab (anti–PD-1 monoclonal antibody) combined with stereotactic radiation therapy, followed by surgery. Key exclusions include prior checkpoint inhibitor therapy, contraindication to re-irradiation, significant immunosuppression, or pembrolizumab hypersensitivity.

ClinicalTrials.gov ID: NCT04977375

Phase I Clinical Trial of GPC2 Chimeric Antigen Receptor T (GPC2-CAR T) Cells for Relapsed or Refractory Medulloblastoma in Children and Young Adults

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Children and young adults (12 months–30 years) with GPC2-positive relapsed/refractory medulloblastoma or other eligible CNS embryonal tumors receive autologous GPC2-directed CAR T cells via intracerebroventricular infusions after fludarabine/cyclophosphamide lymphodepletion. GPC2-CAR T targets glypican-2 (oncofetal heparan sulfate proteoglycan) with locoregional delivery and intrapatient dose escalation over up to 8 cycles.

ClinicalTrials.gov ID: NCT07087002

A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolls adults with locally advanced/metastatic/unresectable solid tumors harboring ERBB2 (HER2) activating alterations, NRG1 fusions, or HER2 overexpression, with expansion cohorts for ERBB2-mutant NSCLC with brain metastases and ERBB2-mutant or HER2-overexpressing breast cancer with brain metastases ± leptomeningeal disease. Patients receive oral CGT4255, an investigational EGFR-sparing selective HER2 tyrosine kinase inhibitor designed to cover multiple oncogenic HER2 mutations with CNS penetration, given at escalating/selected doses.

ClinicalTrials.gov ID: NCT07361562

An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with ECOG 0–1 and locally advanced/metastatic solid tumors, including ER+/HER2− breast cancer, NSCLC, CRPC, and MSS colorectal cancer after prior standard therapy, receive oral IDE574 monotherapy; breast cancer cohorts require prior endocrine therapy and CDK4/6 inhibitor. ER+/HER2− breast cancer patients may receive IDE574, an investigational dual KAT6/KAT7 epigenetic inhibitor, in combination with fulvestrant.

ClinicalTrials.gov ID: NCT07540572

An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with recurrent or progressive WHO grade 3–4 glioma after up to two prior lines of therapy receive daily oral GLIX1 monotherapy until progression or unacceptable toxicity. GLIX1 is an investigational small-molecule TET2 activator intended to enhance 5-methylcytosine oxidation/base excision repair–mediated DNA damage and apoptosis in tumor cells.

ClinicalTrials.gov ID: NCT07464925

Phase 1 Trial of Engineered HSV-1 M032 in Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Enrolls children and adults ≥36 months with newly diagnosed supratentorial H3K27-altered diffuse midline glioma or pontine diffuse midline glioma after completing standard radiation, with a surgically accessible 1–4 cm lesion. Treatment is a single stereotactic intratumoral injection of M032 during craniotomy, an engineered oncolytic HSV-1 with ICP34.5 deletion and IL-12 expression designed for tumor-selective lysis and local antitumor immune activation.

ClinicalTrials.gov ID: NCT07076498