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Monthly Update Report for Trials Started in May 2026


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


Overview

Number of Trials: 8

These eight trials investigate diverse approaches to treating brain tumors and brain metastases across pediatric and adult populations. Five trials focus on primary brain tumors (glioblastoma, glioma, DIPG, medulloblastoma, ATRT, ETMR) while three target brain metastases from breast cancer or neuroblastoma. Therapeutic strategies include targeted small molecules (sitagliptin, zanzalintinib, silevertinib), antibody-drug conjugates (sacituzumab tirumotecan), gene therapy (Ad-hCMV-TK/Flt3L), antiviral repurposing (valganciclovir), polyamine inhibition (DFMO plus AMXT 1501), and cognitive rehabilitation. Several trials combine experimental agents with standard chemotherapy or radiation, while others explore immune-modulating or metabolism-targeting mechanisms.

Common Criteria Across Trials

Common Inclusion

  • Histologically confirmed diagnosis of malignancy
  • Age restrictions varying by trial (pediatric to young adult)
  • Adequate organ function (liver, kidney, bone marrow)
  • Performance status requirements (ECOG 0-2 or Karnofsky/Lansky ≥60)
  • Recovery from prior therapy with specified washout periods
  • Ability to swallow tablets or capsules
  • Negative pregnancy test and contraception requirements for childbearing potential
  • Measurable or evaluable disease
  • Controlled blood pressure in some trials

Common Exclusion

  • Uncontrolled infection or intercurrent illness
  • Pregnant or breastfeeding
  • Other active malignancies within 2-3 years
  • Concurrent investigational agents
  • Known HIV, hepatitis B or C (in some trials)
  • Psychiatric illness affecting compliance
  • Significant cardiovascular disease
  • Prior allergic reactions to study drugs
  • Inadequate organ function
  • Leptomeningeal disease (in some trials)

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT07558473

Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors

Organization/Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.


Example patient: A 12-year-old patient with medulloblastoma diagnosed 2 years ago, currently receiving follow-up care at Johns Hopkins Hospital, with stable disease and no severe cognitive impairment that would prevent participation in computerized training.

Phase N/A

Interventions

  • Behavioral: Online computerized cognitive training intervention focused on processing speed
    Summary: Computer-based training to improve cognitive skills including focus, attention, memory, and information processing, specifically targeting processing speed in pediatric brain tumor patients (NCI Thesaurus).

Key Inclusion

  • Primary tumor located in the brain
  • Diagnosed between 0 and 25 years of age
  • Within five years of cancer diagnosis
  • Receiving care at Johns Hopkins Hospital

Key Exclusion

  • Primary tumor outside of the brain
  • Patients too young to participate (less than 5 years)
  • Severe brain injuries precluding understanding and participation in cognitive intervention

NCT07541781

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

Organization/Sponsor: University of Iowa


Example patient: A 52-year-old man with recurrent WHO grade 4 glioblastoma, ECOG performance status 1, controlled blood pressure, adequate organ function, 6 weeks post-temozolomide, not on insulin, and deemed surgical candidate for pilot phase.

Phase 1

Interventions

  • Biological: Bevacizumab
    Summary: Recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor (VEGF) to block tumor angiogenesis and blood vessel formation, indicated for glioblastoma and other advanced cancers (FDA label, NCI Thesaurus).
  • Drug: Sitagliptin
    Summary: Oral dipeptidyl peptidase-4 (DPP-4) inhibitor that enhances glucose-dependent insulin secretion, approved for type 2 diabetes; may target myeloid-derived suppressor cells in glioma (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed WHO grade 4 glioma with recurrence/progression
  • Age >18 years
  • ECOG performance status 0-2
  • No prior sitagliptin or bevacizumab for this disease
  • Adequate organ function and laboratory parameters
  • Controlled blood pressure (systolic ≤160 mmHg or diastolic ≤100 mmHg)
  • Minimum intervals from prior treatments (surgery 4 weeks, nitrosoureas 6 weeks)
  • Ability to swallow whole tablets

Key Exclusion

  • Prior treatment toxicities not resolved to ≤Grade 1 except alopecia and neuropathy
  • Uncontrolled intercurrent illness including active infection or symptomatic heart failure
  • Other malignancy within past 2 years with specific exceptions
  • Subjects receiving insulin or sulfonylurea for diabetes mellitus
  • History of type 1 diabetes or uncontrolled type 2 diabetes
  • Arterial ischemic event within 6 months of study entry
  • History of hematologic bleeding disorder
  • Pregnant or breastfeeding

NCT06465199

A Phase I/II Study Using Eflornithine (DFMO) and AMXT 1501 for Relapsed and Refractory Neuroblastoma, CNS Tumors, and Sarcomas

Organization/Sponsor: Milton S. Hershey Medical Center


Example patient: A 14-year-old male with relapsed high-risk neuroblastoma after completing 5 cycles of multi-drug induction chemotherapy and immunotherapy, currently stable on recent salvage therapy with no organ involvement, Karnofsky score of 80, and adequate organ function.

Phase 1, Phase 2

Interventions

  • Drug: AMXT 1501 Dicaprate
    Summary: An orally bioavailable polyamine transport inhibitor that blocks polyamine uptake into the tumor microenvironment, inhibiting tumor cell proliferation and inducing apoptosis while potentially reversing polyamine-mediated immune suppression (NCI Thesaurus).
  • Drug: Eflornithine (DFMO)
    Summary: An irreversible inhibitor of ornithine decarboxylase that blocks polyamine biosynthesis, inhibiting tumor cell formation and proliferation and inducing apoptosis (NCI Thesaurus).

Key Inclusion

  • Maximum 26 years of age at diagnosis
  • Confirmed pathologic diagnosis of relapsed/refractory neuroblastoma, ETMR, ATRT, newly diagnosed DIPG, or relapsed/refractory Ewing sarcoma or osteosarcoma
  • DIPG participants must start 30-60 days after standard radiation therapy
  • Lansky or Karnofsky Performance Scale score ≥60
  • Adequate organ function including ANC ≥750/μL, AST/ALT <10x ULN, normal cardiac troponin and BNP, QTcF ≤470 msec
  • Adequate renal function with eGFR ≥70 mL/min/1.73 m²
  • Able to swallow capsules
  • Fully recovered from acute toxic effects of prior chemotherapy with specified washout periods

Key Exclusion

  • BSA <0.25 m²
  • Currently receiving another investigational drug
  • Currently receiving other anticancer agents
  • Uncontrolled infection
  • Unable to comply with safety monitoring requirements
  • Pregnant or lactating without agreeing to stop breastfeeding
  • DIPG participants with progression or recurrence after initial radiation
  • Neuroblastoma participants with active disease in organs including lungs, liver, or brain

NCT07428616

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

Organization/Sponsor: Exelixis


Example patient: A 52-year-old woman with WHO grade 2 recurrent meningioma showing 20% tumor growth over 5 months, previously treated with surgery and radiation 8 months ago, with KPS of 70% and adequate organ function.

Phase 2

Interventions

  • Drug: Zanzalintinib
    Summary: An orally bioavailable inhibitor of receptor tyrosine kinases c-Met, VEGFR2, AXL, and MER with anti-angiogenesis and antineoplastic activities. It blocks RTK-mediated signaling pathways, inhibiting proliferation, migration, invasion, and metastasis of tumor cells overexpressing these receptors. Source: NCI Thesaurus.

Key Inclusion

  • WHO grade 1, 2, or 3 meningioma histologically confirmed
  • Recurrent or progressive disease after standard therapy (surgery and/or radiation)
  • At least 1 prior course of meningioma-directed radiotherapy required if not contraindicated
  • Radiologically documented progression (growth >15% within 6 months or new lesions)
  • Interval ≥24 weeks from completion of radiation therapy to treatment initiation
  • Measurable disease by RANO meningioma criteria obtained ≤14 days prior to treatment
  • Karnofsky performance status ≥60%
  • Adequate organ and marrow function within 14 days of treatment

Key Exclusion

  • Prior history of hypertensive encephalopathy
  • Extracranial lesions invading major blood vessels (inferior vena cava, pulmonary artery, aorta)
  • Contraindication to MRI
  • Local therapy (surgery/radiation) indicated per investigator
  • Systemic anticancer therapy within 4 weeks or 5 half-lives before treatment
  • Major surgery within 8 weeks or minor surgery within 7 days
  • Uncontrolled significant intercurrent illness including cardiovascular or GI disorders
  • Requirement for hemodialysis or peritoneal dialysis

NCT07383649

Initial Safety Lead-in Followed by a Phase II Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (The Breast CMV Study)

Organization/Sponsor: The Methodist Hospital Research Institute


Example patient: A 52-year-old postmenopausal woman with metastatic breast cancer, ECOG status 1, presenting with three progressive brain metastases (one 1.5 cm untreated lesion in non-critical area), positive CMV IgG serology, adequate organ function, and no immediate neurological symptoms requiring intervention.

Phase II

Interventions

  • Drug: Valganciclovir
    Summary: Valganciclovir is an antiviral drug that inhibits viral DNA polymerase to block cytomegalovirus replication, investigated here for treating progressive brain metastases in breast cancer patients with CMV infection (Source: Web Search).

Key Inclusion

  • Breast cancer with progressive brain metastases
  • At least one non-irradiated, untreated progressive brain metastases site
  • Serum HCMV DNA >250 copies/ml or positive CMV IgG or IgM
  • Age >18 years
  • ECOG performance score 0-2
  • Adequate hematology, renal and hepatic function
  • At least 1 lesion ≤2 cm in non-critical brain area spared from SRS
  • Negative pregnancy test for premenopausal females

Key Exclusion

  • Single resectable intracranial lesion
  • Last intracranial progression-free survival >12 months
  • All progressive brain metastases have been radiated
  • Brain metastases needing immediate intervention (mass effect, herniation, near vital structures)
  • Active pregnancy or breastfeeding
  • Other malignancies within 3 years (except non-melanoma skin cancer or cervical carcinoma in situ)
  • Major surgical procedure within 28 days
  • Non-English speaking

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 metastatic triple-negative breast cancer (ER 2%, PR 0%, HER2 0) who previously received sacituzumab govitecan, now presents with three new brain metastases (largest 15 mm) detected on MRI, ECOG performance status 1, no seizures, and adequate organ function.

Phase N/A

Interventions

  • Drug: Sacituzumab tirumotecan
    Summary: An antibody-drug conjugate targeting TROP2-expressing cancer cells, delivering topoisomerase I inhibitor tirumotecan via pH-sensitive linker to induce DNA replication inhibition, cell cycle arrest, and apoptosis with bystander effect (NCI Thesaurus, FDA label).

Key Inclusion

  • Age 18 years or older
  • Metastatic triple-negative breast cancer (ER <10%, PR <10%, HER2-negative)
  • Newly diagnosed or progressing brain metastases
  • Intracranial measurable disease by RANO-BM criteria (≥10 mm contrast-enhancing lesion)
  • ECOG performance status 0-1
  • Prior treatment with antibody-drug conjugate required
  • No immediate need for surgery or radiation therapy
  • Adequate organ function and blood counts

Key Exclusion

  • Prior use of sacituzumab tirumotecan
  • Documented leptomeningeal disease by CSF cytology
  • Uncontrolled seizures (>2 seizures within 28 days)
  • Concurrent anticancer therapy
  • Systemic corticosteroids >8 mg dexamethasone daily
  • Severe dry eye syndrome or corneal disease
  • QTcF interval >480 ms or significant cardiovascular disease within 6 months
  • Current use of strong CYP3A4 inducers/inhibitors

NCT06914479

A Phase 1 Study of a Combined Cytotoxic and Immune-Stimulatory Therapy in Pediatric and Young Adult Patients With Recurrent, Primary Malignant Brain Tumors Genomic-based

Organization/Sponsor: University of Michigan Rogel Cancer Center


Example patient: A 16-year-old male with recurrent H3 G34-mutant diffuse hemispheric glioma who completed standard radiation and chemotherapy six weeks ago, has stable corticosteroid dosing, adequate organ function, Karnofsky score of 70, and is scheduled for surgical resection of progressive tumor.

Phase 1

Interventions

  • Diagnostic: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and magnetic fields to provide detailed pictures of internal organs and tissues, valuable for diagnosing cancer and monitoring treatment response (NCI Thesaurus).
  • Drug: Valacyclovir
    Summary: Nucleoside analog DNA polymerase inhibitor that converts to acyclovir, inhibiting viral DNA replication; used with HSV-tk gene therapy to kill tumor cells expressing thymidine kinase (FDA label, NCI Thesaurus).
  • Procedure: Tumor Resection
    Summary: Surgical procedure to remove cancerous tissue, often combined with other therapies to prevent recurrence and improve outcomes (NCI Thesaurus).
  • Other: Survey Administration
    Summary: Presentation of questionnaires to obtain patient responses, assessing experiences and knowledge in clinical trials (NCI Thesaurus).
  • Other: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for testing and research to analyze genetic and molecular features of cancer (NCI Thesaurus).
  • Biological: Ad-hCMV-TK
    Summary: Replication-defective adenoviral vector expressing HSV thymidine kinase gene; converts prodrugs like valacyclovir into toxic compounds killing tumor cells and stimulating antitumor immune response (NCI Thesaurus).
  • Biological: Ad-hCMV-Flt3L
    Summary: Adenoviral vector expressing Flt3 ligand to stimulate dendritic cell proliferation and migration, initiating immune response against tumor-associated antigens from dying glioma cells (NCI Thesaurus).

Key Inclusion

  • Age 3-25 years with recurrent malignant primary brain tumor after standard therapy
  • Age 26-39 years with diffuse hemispheric glioma H3 G34-mutant after recurrence
  • Surgical resection of tumor recurrence clinically indicated
  • At least 10 kg body weight and BSA >0.5 m²
  • ANC ≥1000/mm³ and platelets ≥100,000/mm³
  • Performance score ≥60 (Karnofsky/Lansky)
  • Recovered from acute side effects of prior therapy with appropriate washout periods
  • Adequate renal and hepatic function

Key Exclusion

  • Not clinically appropriate for tumor resection
  • Evidence of disseminated disease or leptomeningeal spread
  • Primary brainstem or spinal tumors
  • History of prior gene therapy
  • Known immune disorders (HIV, hepatitis B/C, autoimmune disease)
  • Current use of other investigational or anti-cancer agents
  • Pregnancy or breastfeeding
  • History of allogeneic stem cell or kidney transplant

NCT07326566

A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII Genomic-based

Organization/Sponsor: Black Diamond Therapeutics, Inc.


Example patient: A 52-year-old male with newly diagnosed IDH-WT glioblastoma harboring EGFRvIII mutation and unmethylated MGMT promoter who completed surgical resection followed by standard radiation (60 Gy) and temozolomide six weeks ago with stable post-radiation MRI.

Phase 2

Interventions

  • Drug: temozolomide (TMZ)
    Summary: Temozolomide is an oral alkylating agent that methylates DNA at O6 and N7 positions of guanine, inhibiting DNA replication and causing cell death. It is indicated for newly diagnosed glioblastoma with radiotherapy and as maintenance therapy. Source: FDA label, NCI Thesaurus.
  • Drug: silevertinib in combination with temozolomide
    Summary: Silevertinib (BDTX-1535) is an oral EGFR inhibitor combined with temozolomide, an alkylating agent that generates active metabolite MTIC to alkylate DNA. Used for newly diagnosed glioblastoma treatment. Source: FDA label.

Key Inclusion

  • Newly diagnosed IDH-WT glioblastoma
  • Positive EGFR status in brain tumor
  • Part 2: EGFRvIII mutation
  • Part 2: Unmethylated MGMT promoter
  • Standard-of-care radiation (54-60 Gy) and TMZ completed
  • At least 4 weeks post-radiation
  • Post-radiation MRI showing no progression

Key Exclusion

  • Recurrent multifocal, metastatic, leptomeningeal, or extracranial GBM
  • GBM progression prior to enrollment
  • Biopsy-only without resectional surgery
  • Prior EGFR-targeting agents or bevacizumab
  • Prior Gliadel wafers, GammaTile, or intratumoral therapy
  • Intent to use Optune (TTF)
  • Significant uncontrolled health conditions or other malignancies