Clinical Trials for Brain Tumor

A Phase 0, Single-center, Open-label, Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with recurrent, resectable WHO grade 3–4 frontal lobe glioma that is mTOR‑pathway positive (e.g., PTEN loss or PI3K/AKT/mTOR alterations) after prior Stupp regimen receive a single pre-resection dose of temsirolimus given via super-selective intra-arterial infusion or standard IV. Temsirolimus is an mTORC1 inhibitor; the study compares intratumoral drug exposure and target inhibition (pS6) between delivery routes.

ClinicalTrials.gov ID: NCT05773326

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with advanced cancers and actively progressing, measurable, untreated asymptomatic brain metastases (including BRCA1/2-mutated, other HRR-aberrant tumors, SCLC, NSCLC, and TNBC) receive niraparib (PARP inhibitor exploiting HRD/synthetic lethality) plus dostarlimab (PD‑1 inhibitor) to assess intracranial response and durability; prior PD‑1/L1 allowed, prior full‑dose PARP monotherapy excluded. Requires ECOG 0–2, adequate organ function, no leptomeningeal disease, and no need for immediate local therapy or steroids.

ClinicalTrials.gov ID: NCT05700721

Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

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.

HealthScout AI summary: Children and young adults (3 to <22 years) with recurrent or progressive malignant cerebellar brain tumors (e.g., medulloblastoma, high‑grade glioma/GBM, ependymoma, ATRT, PNET, germ cell tumor) with surgically accessible lesions ≤3 cm receive intratumoral G207, an engineered, tumor‑selective oncolytic HSV‑1 (γ34.5 deletions, UL39 inactivation; TK‑retained), with later cohorts also receiving a single 5‑Gy focal radiation dose within 24 hours. Key exclusions include diffuse multifocal disease (≥3 lobes), need for ventricular/brainstem inoculation or access, active infection/immunosuppression, and concurrent anticancer therapy.

ClinicalTrials.gov ID: NCT03911388

A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with 1–4 resectable brain metastases from non-CNS primaries (one 2–5 cm lesion requiring resection; KPS ≥60) are randomized to standard single-fraction SRS either preoperatively (within 7 days before surgery) or postoperatively (to the cavity within 10–30 days). Systemic therapy is generally allowed except cytotoxic/TKI within ±3 days of SRS; key exclusions include prior RT to the index site, leptomeningeal disease, and small cell/germ cell/lymphoma histologies.

ClinicalTrials.gov ID: NCT05438212

DURABLE: Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and rEarrangements

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with treatment-naïve, stage IV ALK-rearranged NSCLC and asymptomatic or minimally symptomatic brain metastases are randomized to alectinib (ALK TKI with strong CNS activity) alone with delayed brain RT versus upfront stereotactic radiosurgery followed by alectinib. Designed to assess neurologic outcomes and CNS control, with a Phase 1b run-in for safety/feasibility of alectinib.

ClinicalTrials.gov ID: NCT05987644

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

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

HealthScout AI summary: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

A Randomized Pivotal Study Assessing the Safety and Efficacy of Targeted Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound During the Standard of Care Treatment of Brain Metastases of Non-small Cell Lung Cancer (NSCLC) Origin

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: Adult patients with NSCLC and measurable brain metastases eligible for immune checkpoint inhibitor therapy are randomized to receive standard ICI treatment alone or in combination with targeted blood-brain barrier opening using Exablate focused ultrasound, a device-based method to enhance drug delivery to brain lesions.

ClinicalTrials.gov ID: NCT05317858

Phase II Trial of Palbociclib and Pembrolizumab in Central Nervous System Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: Adults with progressive, measurable CNS metastases from solid tumors and CDK pathway alterations (Cohort 1) receive palbociclib, a selective CDK4/6 inhibitor, while patients with breast cancer brain metastases (Cohort 2) receive palbociclib plus pembrolizumab, an anti–PD-1 immunotherapy. Prior CNS-directed therapy is allowed; key exclusions include prior CDK4/6 inhibitor use, leptomeningeal disease (Cohort 1), and active autoimmune disease (Cohort 2).

ClinicalTrials.gov ID: NCT02896335

An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: This trial enrolls adults with ER-positive, HER2-negative breast cancer and active, measurable brain metastases who have progressed on prior endocrine therapy (excluding prior abemaciclib in the metastatic setting), testing oral elacestrant (a selective estrogen receptor degrader) in combination with abemaciclib (a CDK4/6 inhibitor). The study excludes patients with leptomeningeal disease, imminent visceral crisis, or prior metastatic abemaciclib exposure.

ClinicalTrials.gov ID: NCT05386108

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

No known activity

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

HealthScout AI summary: This trial enrolls adults with advanced HRR-mutated solid tumors—including previously treated breast, ovarian, fallopian tube, primary peritoneal, castration-resistant prostate, or pancreatic cancers—who may have had limited prior PARP inhibitor exposure and CNS metastases if stable. Patients receive EIK1004 (IMP1707), a highly selective CNS-penetrant PARP1 inhibitor, as oral monotherapy.

ClinicalTrials.gov ID: NCT06907043