Clinical Trials for Brain Tumor

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

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.

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 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

A Phase 1, Open-label Study of Oral BDTX-4933 in Patients With KRAS, BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms

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.

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: This trial enrolls adults with advanced or metastatic solid tumors—such as NSCLC (KRAS non-G12C), melanoma (BRAF/NRAS), histiocytic neoplasms, thyroid carcinoma, colorectal carcinoma (BRAF Class II/III), or other BRAF-mutant tumors—who have exhausted standard therapies, to receive oral BDTX-4933, a brain-penetrant RAF/RAS clamp inhibitor targeting a range of RAS/MAPK pathway mutations. The study includes dose escalation and expansion phases to assess safety and preliminary efficacy.

ClinicalTrials.gov ID: NCT05786924

A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

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.

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 rare primary CNS tumors (e.g., GBM, diffuse midline glioma, ependymoma, medulloblastoma, atypical/anaplastic meningioma) after standard therapy receive oral ONC206 monotherapy. ONC206 is an imipridone that non-competitively antagonizes DRD2/DRD3 and allosterically hyperactivates mitochondrial ClpP, aiming to trigger integrated stress response and apoptosis; dose-escalation with food-effect/PK assessment and potential expansion at RP2D.

ClinicalTrials.gov ID: NCT04541082

A Phase 1/2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma

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.

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: Pediatric patients (12 months–21 years) with relapsed/refractory solid tumors or lymphoma, including CNS tumors; Phase 2 focuses on progressive/recurrent DIPG or other H3 K27–altered diffuse midline gliomas post-radiation. Single-arm IV CBL0137 (a FACT “chromatin-trapping” agent that activates p53, suppresses NF-κB, and induces interferon response) is given on Days 1 and 8 of 21-day cycles to define RP2D and assess antitumor activity.

ClinicalTrials.gov ID: NCT04870944

A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients With Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

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.

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: For pediatric and adult patients with relapsed/refractory high-risk neuroblastoma/ganglioneuroblastoma or osteosarcoma, after standard therapies. Patients receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of autologous GD2-directed CAR T cells engineered to co-express IL-15 (to enhance persistence/function) and an inducible caspase-9 safety switch.

ClinicalTrials.gov ID: NCT03721068