Clinical Trials for Brain Tumor

A Phase 1 Study of a Combined Cytotoxic and Immune-Stimulatory Therapy in Pediatric and Young Adult Patients With Recurrent, Primary Malignant 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: Enrolls children, adolescents, and young adults (3–25 years; up to 39 for recurrent diffuse hemispheric glioma, H3 G34-mutant) with surgically resectable recurrent/progressive malignant primary brain tumors after standard therapy. Treatment is intratumoral/peritumoral AdV-HSV1-TK plus AdV-Flt3L at resection followed by oral valacyclovir; HSV-TK/valacyclovir is a suicide gene cytotoxic strategy, and Flt3L is intended to recruit/activate dendritic cells to enhance antitumor immunity.

ClinicalTrials.gov ID: NCT06914479

A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion

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, adolescents, and young adults (12 months–21 years) with newly diagnosed high-grade glioma, including DIPG/diffuse midline glioma, harboring an ALK or ROS1 fusion receive oral lorlatinib, a brain-penetrant third-generation ALK/ROS1 tyrosine kinase inhibitor, for 2 cycles upfront. Subsequent therapy is response- and age-adapted, with continuation of lorlatinib alone for complete responders, lorlatinib plus pediatric chemotherapy for selected younger patients, or lorlatinib maintenance after focal radiotherapy for older patients.

ClinicalTrials.gov ID: NCT06333899

A Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent Glioblastoma

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 first-recurrent, IDH-wildtype, MGMT promoter–methylated glioblastoma after prior radiotherapy/temozolomide and recurrence surgery/biopsy are randomized to temozolomide alone versus temozolomide followed by selinexor. Selinexor is an oral exportin 1/CRM1 inhibitor intended to restore nuclear retention of tumor suppressor and growth-regulatory proteins.

ClinicalTrials.gov ID: NCT05432804

Targeting Myeloid-Derived Suppressor Cells in Patients With Recurrent/Progressive Grade 4 Glioma: Phase 1 Trial of Sitagliptin

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 progressive WHO grade 4 glioma after first-line therapy who are bevacizumab- and sitagliptin-naive receive oral sitagliptin, a DPP-4 inhibitor intended to reduce immunosuppressive myeloid-derived suppressor cells, plus bevacizumab. Surgical candidates also receive preoperative sitagliptin followed by resection and postoperative combination therapy.

ClinicalTrials.gov ID: NCT07541781

A Phase 1/1b Study of IAM1363 in Patients with Advanced Cancers Harboring HER2 Alterations

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 evaluates IAM1363, an oral, irreversible tyrosine kinase inhibitor targeting HER2 mutations, in adult patients with advanced cancers harboring HER2 alterations who have relapsed or are intolerant to previous therapies, including a subgroup with brain metastases.

ClinicalTrials.gov ID: NCT06253871

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: This trial enrolls adults with advanced or metastatic solid tumors (including IDH-wildtype glioblastoma) harboring MTAP loss who have progressed on standard therapy, and tests TNG456, a selective, brain-penetrant PRMT5 inhibitor, as monotherapy or in combination with abemaciclib (CDK4/6 inhibitor). Eligible patients must have measurable disease, good performance status, and adequate organ function.

ClinicalTrials.gov ID: NCT06810544

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

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.

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.

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.

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 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