Clinical Trials for Brain Tumor

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

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 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors

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: Eligible patients are adults with advanced or metastatic triple-negative breast cancer, high-grade serous ovarian, primary peritoneal, fallopian-tube, or serous endometrial cancer, all with TP53 mutation/loss and progression after at least one prior line of therapy. Participants receive AO-252, an investigational oral small-molecule inhibitor of TACC3 protein-protein interactions.

ClinicalTrials.gov ID: NCT06136884

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (OLAparib) Followed by Adjuvant Combination of DuRvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With BreAst Cancer Brain Metastases

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: This trial enrolls adults with triple negative or BRCA-mutated, HER2-negative breast cancer with new brain metastases suitable for stereotactic radiosurgery, and tests the combination of SRS with olaparib (PARP inhibitor) followed by durvalumab (PD-L1 inhibitor) plus physician’s choice single-agent systemic therapy. Patients with prior whole brain radiotherapy, diffuse leptomeningeal disease, or previous combined PARP and immune checkpoint inhibitor therapy are excluded.

ClinicalTrials.gov ID: NCT04711824

Phase Ia/Ib Open Label, Multi-Centre Dose Escalation Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy in Participants With Advanced Malignancies

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 advanced/metastatic breast, ovarian, or prostate cancer (including patients with known brain metastases), ECOG 0–1, and measurable disease receive oral DSB2455, a PARP1‑selective inhibitor aiming to exploit synthetic lethality in HR‑deficient tumors (e.g., BRCA/HRR alterations); prior first‑line PARP inhibitor exposure is allowed, but prior PARP1‑selective therapy is excluded. Single‑arm dose escalation/expansion evaluates safety and preliminary activity, with CNS penetration highlighted and mandatory biopsies required.

ClinicalTrials.gov ID: NCT06458712

Phase I Study of Intraventricular Infusion of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) in Subjects With Recurrent or Refractory 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 or refractory glioblastoma (supratentorial or infratentorial) post-surgery/biopsy and ≥40.05 Gy RT with concurrent temozolomide, KPS >60%, and no prior anti-angiogenic or CAR T therapy receive up to three weekly intraventricular infusions of autologous CAR T cells targeting B7-H3 (CD276). Therapy is delivered via the ventricular system to enhance CNS distribution; study focuses on safety, CRS/neurotoxicity, and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT05366179

Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma

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/refractory EGFR-overexpressing high-grade gliomas (GBM, anaplastic astrocytoma/oligoastrocytoma) after Stupp protocol receive superselective intra-arterial cetuximab following mannitol BBB disruption plus hypofractionated re-irradiation. Cetuximab is an anti-EGFR IgG1 monoclonal antibody that blocks EGFR signaling and mediates ADCC; eligibility requires measurable disease and KPS ≥60%.

ClinicalTrials.gov ID: NCT02800486

REMASTer: REcurrent Brain Metastases After SRS Trial

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 a single brain metastasis showing radiographic progression after prior SRS are randomized via an intraoperative pathology–guided algorithm to LITT (NeuroBlate MRI-guided thermal ablation) with or without hypofractionated re-irradiation if recurrent tumor, or to LITT plus steroids versus steroids alone if radiation necrosis. Designed to test local control after ablation in true recurrence and time to steroid independence in radiation necrosis.

ClinicalTrials.gov ID: NCT05124912

Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With GD2-expressing Brain Tumors (GAIL-B)

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: Pediatric and young adult patients (12 months–22 years) with GD2-expressing CNS tumors—including diffuse midline glioma/high-grade glioma and select other high-grade brain tumors—receive lymphodepletion (cyclophosphamide/fludarabine) followed by autologous GD2-directed CAR T cells engineered with a constitutively active IL‑7 receptor (C7R) to enhance persistence. Cohort 1 gets initial IV CAR T then intracerebroventricular dosing via Ommaya/VP shunt; Cohort 2 (recurrent/progressive pontine HGG or H3K27-altered DMG) receives IV only.

ClinicalTrials.gov ID: NCT04099797

SJ901: Phase 1/2 Evaluation of Single Agent Mirdametinib (PD-0325901), a Brain-Penetrant MEK1/2 Inhibitor, for the Treatment of Children, Adolescents, and Young Adults With Low-Grade Glioma

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: Enrolling patients aged 2 to <25 years with centrally confirmed MAPK-activated WHO grade I–II pediatric low-grade glioma (including eligible glioneuronal/neuroepithelial tumors), across newly diagnosed and recurrent/progressive settings, with measurable/evaluable disease; excludes BRAF V600, NTRK/ALK/ROS1 fusions, IDH1/2, and significant ocular/cardiac/hepatic/pulmonary comorbidity. Investigational therapy is oral single-agent mirdametinib, a selective brain-penetrant MEK1/2 inhibitor targeting MAPK/ERK signaling, given BID in 28-day cycles; cohorts include MEK inhibitor–naïve and previously MEK-exposed patients.

ClinicalTrials.gov ID: NCT04923126

A Phase I Study of RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)

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 supratentorial GBM post–surgery and temozolomide (KPS ≥60) receive intravenous RNA–lipid particle vaccines: three priming doses of pp65 mRNA-LP (targets CMV pp65, LAMP-enhanced MHC II presentation) followed by monthly doses combining pp65 mRNA with autologous tumor RNA; randomized to start priming before vs after biopsy/resection. Excludes prior bevacizumab and significant immunosuppression/autoimmunity; aims to assess feasibility, safety, and MTD.

ClinicalTrials.gov ID: NCT06389591