Clinical Trials for Brain Tumor

Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected 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.

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.

TrialFetch AI summary: Adults with a 3–6 cm unresected brain metastasis or postoperative radiotherapy target from a nonhematologic malignancy (excluding small cell lung cancer and germ cell malignancy) receive adaptive dose-escalated fractionated stereotactic radiation therapy to one dominant target. Concurrent chemotherapy and targeted therapy are prohibited during radiation.

ClinicalTrials.gov ID: NCT03726359

Pilot Study of 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy (SBRT) for Oligo-Progressive Non-Small Cell Lung Cancer (NSCLC)

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 stage IV NSCLC receiving single-agent pembrolizumab who have both oligoprogressive and nonprogressing lesions undergo SBRT to up to six oligoprogressive sites while continuing pembrolizumab; selected nonprogressing lesions may receive low-dose radiation. They also receive investigational 64Cu-DOTA-pembrolizumab, a radiolabeled PD-1–targeting antibody used for PET imaging before and after radiation rather than as an additional therapeutic dose.

ClinicalTrials.gov ID: NCT07619599

A Safety and Feasibility Study of NeuroNavigation-Guided Low Intensity Focused Ultrasound With Microbubbles to Enhance Nivolumab Delivery for the Treatment of Relapsed and Progressive Diffuse Midline Glioma and Other High Grade Brain Tumors

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: Patients aged 3–25 years with previously treated, relapsed or progressive brainstem diffuse midline glioma or another high-grade intracranial tumor requiring resection receive nivolumab, an anti–PD-1 antibody, after focused ultrasound and microbubbles temporarily open the blood-brain barrier. Patients in the surgical cohort also undergo a focused-ultrasound procedure before resection.

ClinicalTrials.gov ID: NCT07664176

A Phase 1/2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG456 Monotherapy and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

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 or metastatic MTAP-loss solid tumors, including NSCLC and recurrent or progressive glioblastoma, whose standard treatment has failed or is unsuitable or unavailable receive oral TNG456 alone or with abemaciclib. TNG456 is an investigational PRMT5 inhibitor designed to preferentially inhibit PRMT5 in MTAP-loss tumors; abemaciclib inhibits CDK4/6.

ClinicalTrials.gov ID: NCT06810544

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

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) or Hormone Receptor Positive (HR+) Breast Cancer.

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 study enrolls female patients with triple negative, HER2+, or hormone receptor positive breast cancer and asymptomatic, measurable brain metastases, treating them with a personalized anti-HER2/HER3 dendritic cell vaccine (designed to enhance immune targeting of HER2/HER3-expressing cells) combined with the PD-1 inhibitor pembrolizumab. Eligible patients must have ECOG 0-1 and no immediate need for local brain therapy, leptomeningeal disease, or active autoimmune/infectious conditions.

ClinicalTrials.gov ID: NCT04348747

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 locally advanced or metastatic breast, ovarian, or prostate cancer and MRI-confirmed brain metastases receive oral DSB2455, an investigational selective PARP1 inhibitor targeting DNA-damage repair. Eligible patients must have measurable disease, ECOG performance status 0–1, and a safely accessible lesion for biopsy; prior selective PARP1 inhibition is excluded.

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

A Feasibility Study Examining the Use of Non-Invasive Focused Ultrasound (FUS) With Oral Etoposide Administration in Children With Progressive Diffuse Midline Glioma (DMG)

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: Children and young adults (4–21) with progressive diffuse midline glioma of the pons and/or thalamus (including H3K27M-mutant) receive non-invasive focused ultrasound with microbubbles and neuronavigation to transiently open the BBB at tumor-adjacent sites, combined with concurrent oral etoposide (topoisomerase II inhibitor). Key exclusions include prior etoposide, implanted devices, uncontrolled seizures, significant cardiac/QTc issues, coagulopathy/anticoagulation, and inability to tolerate MRI/anesthesia.

ClinicalTrials.gov ID: NCT05762419

Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)

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 GBM undergoing planned ≥80% re-resection receive a laparoscopically harvested autologous omental tissue graft lining the resection cavity to bypass the BBB and potentially enhance local delivery/trafficking of therapeutics and immune cells. Single-arm safety study; excludes multifocal/leptomeningeal disease and patients unable to safely undergo omentum harvest.

ClinicalTrials.gov ID: NCT05979064