Clinical Trials for Brain Tumor

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Adults with HER2-negative metastatic breast cancer and ECOG 0–2 are eligible if they have ER-positive brain metastases after endocrine therapy, triple-negative brain metastases, or leptomeningeal disease of any ER status. All receive datopotamab deruxtecan, a TROP2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor, every 21 days; there is no comparator arm.

ClinicalTrials.gov ID: NCT06176261

A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Patients with measurable, recurrent or progressive WHO grade 1–3 meningioma after standard therapy receive once-daily oral zanzalintinib. Prior radiotherapy is required unless contraindicated; zanzalintinib is an investigational multikinase inhibitor targeting VEGFR2, MET, TYRO3, AXL, and MER.

ClinicalTrials.gov ID: NCT07428616

A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer, with or without CNS metastases (including leptomeningeal disease), are eligible if they have received prior metastatic anti-HER2 therapy and are TKI-naïve in the advanced setting. They are randomized to the blood-brain barrier–penetrant HER2 tyrosine kinase inhibitor RO7771950 or tucatinib, each combined with trastuzumab and capecitabine.

ClinicalTrials.gov ID: NCT07413939

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Adults with advanced or metastatic solid tumors harboring homozygous MTAP deletion receive BMS-986504, an investigational MTA-cooperative PRMT5 inhibitor, alone or in tumor-specific combinations. Combination cohorts pair it with pumitamig (a PD-L1/VEGF-A bispecific antibody) and chemotherapy; daraxonrasib (a RAS(ON) inhibitor), with or without chemotherapy; nivolumab plus relatlimab; or temozolomide and radiotherapy.

ClinicalTrials.gov ID: NCT07492680

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Adults with unresectable or metastatic NSCLC or other solid tumors with MET alterations or dysregulation, including selected primary CNS tumors, receive oral vebreltinib, a selective MET tyrosine-kinase inhibitor. Patients with EGFR-mutant NSCLC and acquired MET amplification after initial benefit from first-line EGFR inhibition receive vebreltinib added to their EGFR inhibitor.

ClinicalTrials.gov ID: NCT03175224

A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Adults with newly diagnosed IDH-wild-type, MGMT-promoter-unmethylated glioblastoma who have completed radiotherapy, with or without temozolomide, receive implanted SonoCloud-9 ultrasound-mediated blood–brain barrier opening with liposomal doxorubicin and two investigational checkpoint antibodies: balstilimab (anti-PD-1) and botensilimab (Fc-engineered anti-CTLA-4).

ClinicalTrials.gov ID: NCT05864534

A Multicenter, Phase II Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

TrialFetch AI summary: Adults with non-uveal melanoma and at least one measurable, previously untreated brain metastasis are enrolled in separate asymptomatic and symptomatic cohorts; the symptomatic cohort permits stable or tapering dexamethasone up to 4 mg/day. All patients receive ipilimumab (CTLA-4 blockade) plus nivolumab (PD-1 blockade) and relatlimab (LAG-3 blockade).

ClinicalTrials.gov ID: NCT06712927

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

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.

TrialFetch AI summary: Adults with recurrent IDH-mutant astrocytoma or IDH-wildtype glioblastoma after radiation-based treatment receive oral NEO212 alone; patients with selected solid tumors and brain metastases uncontrolled by surgery or radiation receive it with tumor-appropriate standard-of-care therapy. NEO212 is an investigational temozolomide–perillyl alcohol conjugate that acts as a DNA-alkylating agent.

ClinicalTrials.gov ID: NCT06047379

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)

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.

TrialFetch AI summary: Adults with metastatic triple-negative breast cancer, measurable brain metastases eligible for stereotactic radiosurgery, ECOG performance status 0–2, and prior taxane- and anthracycline-based chemotherapy receive radiosurgery followed by sacituzumab govitecan and zimberelimab; leptomeningeal disease is excluded. Sacituzumab govitecan is a TROP-2–directed antibody–drug conjugate that delivers SN-38, and zimberelimab is an investigational PD-1–blocking antibody.

ClinicalTrials.gov ID: NCT06238921

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

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.

TrialFetch AI summary: Adults with recurrent advanced or metastatic breast, ovarian, castration-resistant prostate, or pancreatic cancer harboring selected deleterious HRR gene mutations receive oral EIK1004 (IMP1707) monotherapy. EIK1004 is an investigational PARP1-selective inhibitor designed to impair DNA repair and trap PARP1 on DNA while largely sparing PARP2.

ClinicalTrials.gov ID: NCT06907043