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

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 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 I, Multicentre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD1390 in Combination With Radiation Therapy in Patients With Glioblastoma Multiforme and Brain Metastases From Solid Tumors.

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 CNS tumors receiving radiotherapy: recurrent/relapsed GBM (IMRT 35 Gy/2 weeks) and newly diagnosed GBM with unmethylated MGMT (IMRT 60 Gy/6 weeks) are treated with concurrent oral AZD1390, a brain-penetrant ATM kinase inhibitor radiosensitizer; the closed arm previously enrolled patients with brain metastases not suitable for SRS. Key eligibility includes KPS ≥60 and MRI suitability; exclusions include strong CYP3A4 modulators and significant comorbidities.

ClinicalTrials.gov ID: NCT03423628