Brain Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in August 2026

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1: Summary data from new trials identified for Brain Cancer.

Overview

Number of Trials: 7

These 7 trials span pediatric and adult brain tumors and metastases, exploring novel imaging agents, targeted therapies, CAR T cells, radiosurgery, and perioperative steroid management. Interventions include fluorescence-guided surgery agents, antibody-drug conjugates, CAR T therapy, and radiotracers for dosimetry studies.

Common Criteria Across Trials

Common Inclusion

Histologically or radiographically confirmed tumor diagnosis
Adequate organ and marrow function
Negative pregnancy test/contraception requirements for women of childbearing potential
Minimum performance status thresholds (KPS/ECOG/Lansky)
Life expectancy exceeding a minimum threshold
Willingness to provide informed consent

Common Exclusion

Pregnant or breastfeeding individuals
Uncontrolled cardiovascular or cerebrovascular disease
Active uncontrolled infections (HIV, HBV, HCV)
Recent investigational drug or major surgery exposure
Significant comorbidities interfering with study compliance
History of hypersensitivity to study agents

Outcomes Summary

Primary Outcomes

Safety and tolerability of investigational agent (5 trials)
Feasibility or dosimetry of imaging/radiotracer agent (3 trials)
Efficacy or tumor response assessment (3 trials)

Secondary Outcomes

Progression-free survival (2 trials)
Overall survival (2 trials)
Pharmacokinetics/biodistribution (2 trials)
Neurocognitive or quality-of-life outcomes (1 trials)

2: Extracted Trials with New Information

Trials with Special Criteria

Genomic / Biomarker Trials

NCT04085887 — Targets EGFR expression for tumor visualization via imaging agent.
NCT07458113 — Requires ER/PR <10% and HER2-negative status confirming triple-negative breast cancer subtype.
NCT07680439 — Targets B7-H3 antigen expression on glioma cells via CAR T cell engineering.

Unique or Unusual Criteria

NCT07044557 — Excludes any dexamethasone use, unusual for neurosurgical brain metastasis trials.
NCT07733674 — Requires washout from statins due to potential interaction with radiotracer.
NCT06907485 — Excludes patients unable to swallow oral 5-ALA solution, a practical rather than clinical criterion.

Trials with Emerging Treatments

NCT04085887 — Panitumumab IRDye800 Optical Imaging in Pediatric Neoplasms
Items: PDE-NEO-II, Explorer Air camera, Pinpoint-IR9000 device, Panitumumab-IRDye800
Note: Combines novel peptide neoantigen vaccine and fluorescence-guided imaging devices without FDA-approved status.
NCT07680439 — BCB-276 CAR T Cell Therapy for DIPG
Items: BCB-276
Note: Investigational CAR T cell therapy targeting B7-H3 for pediatric brainstem glioma, no prior FDA approval.
NCT07733674 — Dosimetry of 203Pb-RMX-VH-PIB in Solid Tumors
Items: 203Pb-RMX-VHPIB injection
Note: Novel radiolabeled peptide tracer for tumor imaging, not yet FDA approved.
NCT07044557 — MeDex: No Perioperative Dexamethasone in Brain Metastases
Items: Withholding perioperative Dexamethasone
Note: Tests novel approach of omitting standard corticosteroid use to study immune impact.

3: Individual Trial Overviews

NCT04085887

Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures

Organization/Sponsor: Stanford University

Example patient: A 10-year-old boy with a suspected supratentorial glioma scheduled for standard-of-care resection, with normal cardiac and renal function and no prior monoclonal antibody reactions.

Phase 1, Phase 2

Interventions

Biologic/Imaging Agent: Panitumumab-IRDye800
Summary: EGFR-targeted monoclonal antibody conjugated to near-infrared dye IRDye800; binds EGFR-expressing tumor cells enabling fluorescence imaging during surgery to detect pediatric brain neoplasms. Source: FDA label, NCI Thesaurus, Web Search.
Vaccine: PDE-NEO-II
Summary: Peptide-based personalized neoantigen vaccine targeting tumor-specific mutations to stimulate anti-tumor immune response in brain cancer. Source: Web Search.
Device: Explorer Air camera
Summary: Imaging device used with focused ultrasound to open blood-brain barrier and monitor brain tumor microenvironment for improved treatment access. Source: Web Search.
Device: Pinpoint-IR9000 endoscopic/handheld device
Summary: Handheld/endoscopic infrared imaging device used intraoperatively, potentially with photodynamic mechanisms, to visualize and target cancerous tissue during pediatric surgery. Source: Web Search, NCI Thesaurus.

Key Inclusion

Suspected brain tumor undergoing standard-of-care surgical resection
Eligible for resection per operating surgeon
Age 6 months to 25 years
Life expectancy greater than 12 weeks
May have had prior chemotherapy/radiation or biopsy

Key Exclusion

Investigational drug within 30 days prior to dosing
Recent MI, CVA, uncontrolled CHF, unstable angina, or significant liver disease
History of infusion reactions to monoclonal antibodies
Pregnant or breastfeeding
QTc prolongation on ECG
Electrolyte abnormalities below institutional normal limits
Serum creatinine >1.5x upper reference range
Not deemed candidate for optimal tumor resection

NCT07802353

PReoperative Dose Escalated Stereotactic radioSurgery for Resectable Brain Metastases (PRESS)

Organization/Sponsor: Memorial Sloan Kettering Cancer Center

Example patient: A 58-year-old woman with metastatic NSCLC and a single 3cm resectable brain metastasis, KPS 90, no prior brain radiation or leptomeningeal disease, eligible for preoperative SRS followed by surgery.

Phase N/A

Interventions

Procedure: Surgical Resection
Summary: Surgical removal of intracranial metastatic lesion to reduce tumor burden and obtain pathologic confirmation; performed after preoperative SRS per protocol. Source: NCI Thesaurus, Summary of Web Search.
Radiation: Stereotactic Radiosurgery
Summary: Non-surgical technique delivering high-dose targeted radiation preoperatively to brain metastasis to improve local control while sparing surrounding brain tissue. Source: NCI Thesaurus, Summary of Web Search.

Key Inclusion

Confirmed breast, NSCLC, melanoma, or GI cancer
At least one resectable brain metastasis ≤6cm
No prior SRS to index lesion
No leptomeningeal disease
No prior craniotomy/craniectomy
Age ≥18
KPS ≥70, survival >1 year
Able to undergo contrast MRI brain

Key Exclusion

Pregnant or breastfeeding
Prior whole brain radiotherapy
Neurologic instability requiring urgent surgery
Unresolved grade ≥2 radiation toxicity
Non-compliance risk per investigator judgment

NCT06907485

A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration

Organization/Sponsor: University of Pittsburgh

Example patient: A 10-year-old boy with a newly diagnosed cerebellar pilocytic astrocytoma scheduled for resection, normal organ function, no history of porphyria or GI disease, able to swallow oral medication.

Phase N/A

Interventions

Drug: Aminolevulinic acid hydrochloride
Summary: Oral pro-drug converted to protoporphyrin IX, which accumulates in tumor cells and fluoresces under blue light to aid intraoperative visualization and resection of pediatric brain tumors; also used in photodynamic therapy. Source: FDA label, NCI Thesaurus, Web Search summary.

Key Inclusion

New or recurrent primary pediatric brain tumor requiring planned resection
Specific tumor histologies (e.g., astrocytoma, medulloblastoma, ependymoma, PNET, ATRT)
Age 2 to 17 years 182 days
Normal organ and marrow function
Negative pregnancy test if applicable
Ability to provide informed consent/assent

Key Exclusion

Unable to swallow 5-ALA solution
Brain stem tumors
Allergy to compounds similar to 5-ALA
Personal or family history of porphyria
Uncontrolled illness or psychiatric/social issues limiting compliance
Pregnant or breastfeeding
History of GI perforation, diverticulitis, or peptic ulcer disease

NCT07680439

A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma

Organization/Sponsor: BrainChild Bio, Inc

Example patient: A 7-year-old child with imaging-confirmed DIPG who recently completed standard radiation therapy, has a CNS reservoir catheter placed, good performance status, and no metastatic disease or other exclusions.

Phase 2

Interventions

Biological/CAR T Cell Therapy: BCB-276
Summary: BCB-276 is an autologous CAR T cell therapy targeting B7-H3, engineered from a patient's own immune cells to attack DIPG tumor cells locoregionally. Holds FDA breakthrough designation. Source: Summary of Web Search.

Key Inclusion

Age 1 to 26 years, weight ≥10kg
Diagnosis of DIPG via imaging with/without biopsy
CNS reservoir catheter placed prior to first dose
Completed standard radiation therapy within 6 weeks of enrollment
Performance status ≥60 (Lansky/Karnofsky)
Adequate organ function and stable/improving neurologic symptoms
Agrees to highly effective contraception if applicable
Consent for 15-year long term follow up

Key Exclusion

Prior tumor-directed therapy other than radiation/temozolomide
Evidence of metastatic disease
High or increasing corticosteroid requirement
Severe swallowing difficulties
Active malignancy other than DIPG
Active/uncontrolled HIV, Hepatitis B or C
Pregnant or breastfeeding

NCT07458113

Sacituzumab Tirumotecan to Treat Patients With Brain Metastases From Triple-negative Breast Cancer

Organization/Sponsor: Yale University

Example patient: A 52-year-old woman with ER/PR-negative, HER2-negative metastatic breast cancer and new asymptomatic brain metastases, ECOG PS 1, previously treated with an antibody-drug conjugate, with no seizures, stable organ function, and no leptomeningeal disease on CSF cytology.

Phase N/A

Interventions

Antibody-drug conjugate: Sacituzumab Tirumotecan
Summary: TROP2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor (tirumotecan) to cancer cells, causing DNA damage, cell cycle arrest, and apoptosis, with bystander cytotoxic effect; being studied for CNS activity in TNBC brain metastases. Sources: NCI Thesaurus, FDA label, Web Search Summary.

Key Inclusion

Age ≥18 years
Histologically confirmed metastatic triple-negative breast cancer (ER<10%, PR<10%, HER2-negative)
Newly diagnosed or progressing brain metastases
Intracranial measurable disease per RANO-BM (not mandatory)
No immediate need for surgery/radiation
No documented leptomeningeal disease by cytology
ECOG PS 0-1
Prior therapy must include an antibody-drug conjugate

Key Exclusion

Prior use of sacituzumab tirumotecan
Hypersensitivity to sacituzumab tirumotecan
Concurrent anticancer therapy other than bone-targeted agents
Uncontrolled seizures or significant CNS/psychiatric disorders
Severe pulmonary compromise
Pregnant or lactating women
Uncontrolled cardiovascular/cerebrovascular disease or QTc >480ms
Grade >2 pneumonitis/interstitial lung disease

NCT07044557

MeDex: No Perioperative Dexamethasone in Brain Metastases

Organization/Sponsor: University of Louisville

Example patient: A 55-year-old ambulatory patient with a single 3 cm brain metastasis from breast cancer, ECOG 1, no recent steroid use, scheduled for craniotomy resecting most of the tumor.

Phase N/A

Interventions

Procedure/Drug Withholding: Withholding perioperative Dexamethasone
Summary: Study evaluates withholding perioperative dexamethasone, a corticosteroid that normally reduces brain edema via glucocorticoid receptor agonism, to assess safety and reduce immunosuppressive effects during craniotomy for brain metastases. Source: FDA label; Summary of Web Search.

Key Inclusion

New brain tumor(s) on imaging
Visceral mass suspicious or confirmed for neoplasm
No contraindications for craniotomy
Age ≥ 18 years
ECOG performance status ≤ 2
Midline shift on MRI ≤ 10 mm
Craniotomy planned to resect >75% of enhancing mass

Key Exclusion

Unresectable brain metastases >2 cm
>4 unresectable brain metastases ≥2 cm
Prior laser interstitial thermal therapy
High concern for primary CNS lymphoma
Diagnosis of small cell lung carcinoma
Any receipt of dexamethasone
Steroid use in past month
Stage 4 chronic kidney disease (GFR<30)

NCT07733674

Dosimetry and Bio-distribution of 203Pb-RMX-VH-PIB in Newly Diagnosed or Recurrent Patients With Solid Tumors: A Phase I Exploratory Study Genomic-based

Organization/Sponsor: Radiomedix, Inc.

Example patient: A 55-year-old man with recurrent IDH-wild-type GBM, Karnofsky score 80, off chemotherapy for 3 weeks, with normal renal/liver function and no statin use, eligible for imaging study.

Phase 1

Interventions

Imaging Procedure: SPECT/CT Imaging
Summary: Dual-modality imaging combining SPECT functional data with CT structural detail to assess biodistribution and tumor uptake of radiotracer. Source: NCI Thesaurus, Web Search.
Radiopharmaceutical/Diagnostic Agent: 203Pb-RMX-VHPIB injection
Summary: Peptide-based radiotracer labeled with lead-203 used to visualize tumors via SPECT/CT for dosimetry and biodistribution assessment in GBM and PDAC. Source: Web Search.

Key Inclusion

Age ≥18 years
Karnofsky status ≥60
Histologically confirmed or highly suspicious GBM or PDAC
Tumor size ≥1.0 cm by MRI/CT
No antiangiogenic therapy within 4 weeks (GBM)
No chemotherapy within 2 weeks
Stable/decreasing corticosteroid dose (GBM)
Adequate blood counts, renal and liver function

Key Exclusion

Known hypersensitivity to RMX-VH peptide or 203Pb
Inability to undergo MRI/CT/SPECT scans
Pregnancy or breastfeeding
Severe renal impairment or contrast contraindication
Uncontrolled psychiatric/somatic disease
Current statin use unless discontinued
Contraindication to gadolinium or iodinated contrast
Unstable cardiac condition