Clinical Trials for Brain Tumor

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: Adults with 1-8 intact (unresected), non-brainstem brain metastases from solid tumors (such as NSCLC, melanoma, breast, renal, or GI cancers), good performance status, and no prior brain radiotherapy are randomized to receive either single-session stereotactic radiosurgery (SRS) or fractionated SRS (three sessions). Both approaches are non-invasive, high-precision outpatient radiotherapy options for brain metastases.

ClinicalTrials.gov ID: NCT06500455

Phase I Study of Replication-Competent Adenovirus-Mediated Double Suicide Gene Therapy With Stereotactic Radiosurgery in Patients With Recurrent or Progressive High Grade Astrocytomas

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.

HealthScout AI summary: Adults with recurrent or progressive high-grade astrocytoma (glioblastoma or anaplastic astrocytoma) undergoing surgical debulking receive a single intraoperative intratumoral injection of a replication-competent adenovirus (Ad5-yCD/mutTKSR39rep-ADP) carrying yeast cytosine deaminase and mutant HSV1-thymidine kinase plus adenovirus death protein, followed by fractionated stereotactic radiosurgery. Postoperatively, patients take 5-fluorocytosine and valganciclovir to activate intratumoral prodrug-to-toxin conversion and enhance oncolysis/radiosensitization; key exclusions include immunosuppression, active infections, viral hepatitis/HIV, and prior intratumoral gene/viral therapies.

ClinicalTrials.gov ID: NCT05686798

A Multi-Center Phase I Dose Escalation Study of Avutometinib, a RAF/MEK Clamp, in Pediatric Patients With Refractory or Recurrent Solid Tumors Harboring Activating MAPK Pathway Alterations

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.

HealthScout AI summary: Pediatric and young adult patients (3–30 years) with refractory or recurrent solid tumors, including CNS tumors, harboring activating MAPK pathway alterations (e.g., BRAF/RAF fusions or mutations, RAS, PTPN11, SOS1/2, NF1 loss) receive oral avutometinib. Avutometinib is a first-in-class RAF/MEK “clamp” that allosterically inhibits RAF and MEK to suppress MAPK signaling; prior RAF/MEK monotherapy is allowed, and key exclusions include significant ocular, cardiac, or rhabdomyolysis risk.

ClinicalTrials.gov ID: NCT06104488

A Three-part, Phase I/II Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 With Subsequent Extension of Optimal Dose in Recurrent GBM Subjects

Active drug

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

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 first-recurrent, supratentorial, IDH-wildtype GBM (KPS ≥70%) receive the investigational CMV-targeted vaccine VBI-1901—a virus-like particle presenting gB (humoral) and pp65 (T-cell) antigens—given with GM-CSF or AS01B; the randomized extension compares VBI-1901 + GM-CSF versus single-agent nitrosourea (lomustine or carmustine). Key exclusions include high-dose steroids, significant CMV viremia, autoimmune/immunosuppressive conditions, multifocal/leptomeningeal disease, and IDH-mutant tumors.

ClinicalTrials.gov ID: NCT03382977

A Phase Ib Open-label, Multi-center, Dose Escalation Trial of BI 764532 Given as Monotherapy Administered by Repeated Intravenous Infusions in Patients With Glioma Expressing DLL3

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.

HealthScout AI summary: Adults with recurrent/progressive diffuse glioma that is DLL3-positive by central IHC after standard therapy receive BI 764532 monotherapy as intravenous infusions in a single-arm dose-escalation setting. BI 764532 is a DLL3×CD3 bispecific T‑cell engager redirecting T cells to DLL3-expressing tumor cells; key exclusions include leptomeningeal/extracranial disease, prior DLL3‑directed therapy, and recent anti‑VEGF agents.

ClinicalTrials.gov ID: NCT05916313

ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics

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: This trial enrolls adults with EGFR-mutant NSCLC and at least one measurable brain metastasis (≥1 cm) who are TKI-naïve or recently started osimertinib, randomizing them after 3 months of osimertinib to either continue osimertinib alone or add stereotactic radiosurgery (SRS) to residual brain metastases. It excludes patients with prior brain-directed radiotherapy, leptomeningeal disease, or more than 20 brain metastases after initial TKI therapy.

ClinicalTrials.gov ID: NCT06741085

Phase II Study of Adagrasib + Stereotactic Radiosurgery (SRS) for Patients With Metastatic KRAS G12C-mutated NSCLC With Untreated 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: This trial enrolls adults with metastatic KRAS G12C-mutated NSCLC and untreated brain metastases (up to 10 lesions, none >3 cm), who are either treatment-naïve or have received up to two prior lines of therapy, to receive combination therapy with the selective KRAS G12C inhibitor adagrasib plus stereotactic radiosurgery. Prior KRAS G12C inhibitor therapy is not allowed.

ClinicalTrials.gov ID: NCT06248606

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid 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: This trial enrolls adults with HER2-positive advanced solid tumors, including breast cancer patients with or without brain metastases who have progressed on prior anti-HER2 therapy, to receive the investigational brain-penetrant HER2-selective tyrosine kinase inhibitor ZN-A-1041 as monotherapy or in combination with standard anti-HER2 agents such as T-DM1, T-DXd, PHESGO, or Herceptin plus Perjeta. ZN-A-1041 is an oral agent designed to overcome blood-brain barrier limitations and is being evaluated for safety and preliminary efficacy in this setting.

ClinicalTrials.gov ID: NCT05593094

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with 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: This trial enrolls adults with HER2-negative metastatic breast cancer and measurable brain metastases (ECOG 0-1, ≤3 prior chemo regimens) to receive utidelone, a microtubule-stabilizing epothilone analog, alone or with capecitabine. Key exclusions include prior capecitabine failure, leptomeningeal disease, or lesions needing urgent intervention.

ClinicalTrials.gov ID: NCT06764940

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study

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: This trial enrolls adults with advanced or metastatic solid tumors who developed IL-17–mediated immune-related adverse events after immunotherapy and require systemic steroids, testing brodalumab (an IL-17 receptor A inhibitor) as a potential steroid-sparing treatment for irAEs. Patients receive subcutaneous brodalumab alongside a planned steroid taper.

ClinicalTrials.gov ID: NCT06673329