Sophic Logo gordian knotBrain Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in March 2026


Powered by Sophic Starlight


Disclaimer and Important Notice:

Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is provided for educational and consulting purposes only. This report is not a substitute for professional medical advice, diagnosis, or treatment. Sophic shall not be held responsible for any interpretation, application, or use of this report beyond these purposes.

The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. Reports are provided entirely free of charge, and patients should never be billed or charged for access to this information. Users agree to reference Sophic in any publication, presentation, or publicity that incorporates or relies upon information from Sophic Starlight Cancer Clinical Trials Intelligence Reports.


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


Overview

Number of Trials: 10

These 10 trials investigate diverse approaches to brain and systemic cancers, including imaging agents for tumor detection, novel therapeutics for gliomas and breast cancer, neuroprotective strategies during radiation, and neuromuscular rehabilitation. Several trials focus on brain tumor imaging and surgical guidance using fluorescent tracers and PET radiotracers. Others test experimental small molecules, immunotherapies, and thermal ablation techniques for recurrent gliomas. Additional studies explore cognitive preservation during brain radiation and repurposing existing drugs for cancer-related cognitive impairment and tumor growth inhibition.

Common Criteria Across Trials

Common Inclusion

  • Age 18 years or older
  • Histologically confirmed or suspected malignancy
  • Adequate organ function (liver, kidney, bone marrow)
  • ECOG or Karnofsky performance status adequate
  • Ability to provide informed consent
  • Negative pregnancy test for women of childbearing potential
  • Use of effective contraception during study
  • Recovery from prior treatment toxicities
  • Stable or decreasing corticosteroid dose

Common Exclusion

  • Pregnancy or breastfeeding
  • Active uncontrolled infection
  • Severe cardiac disease or recent cardiovascular events
  • Contraindications to MRI or PET imaging
  • Prior malignancy within specified timeframe
  • Severe hepatic or renal impairment
  • Autoimmune disease or immunosuppression
  • Known hypersensitivity to study agents
  • Participation in other investigational studies
  • Life expectancy less than specified months

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


NCT04569591

Desmopressin (DDAVP) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease

Organization/Sponsor: National Institutes of Health Clinical Center (CC)


Example patient: A 14-year-old with biochemically confirmed Cushing's disease, negative pituitary MRI from 3 months ago, normal liver and kidney function, controlled blood pressure, and previous tolerance to DDAVP during diagnostic workup.

Phase N/A

Interventions

  • Drug: Desmopressin acetate
    Summary: A vasopressin analog that mimics natural pituitary hormone 8-arginine vasopressin to enhance renal water conservation via V2 receptor affinity. Used for antidiuretic replacement in central diabetes insipidus and increases circulating factor VIII in hemophilia. In this trial, used to stimulate ACTH-producing pituitary adenomas for FDG-PET detection. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Age 8 or older with biochemical evidence of Cushing's disease
  • Clinical MRI result negative or possible adenoma
  • MRI of pituitary with and without contrast within 9 months
  • IPSS required for newly diagnosed cases
  • Ability to undergo PET-imaging without general anesthesia
  • Surgical candidate agreeing to resection within 24 weeks of PET
  • Normal liver function tests within 14 days
  • Tolerance of previous DDAVP infusion

Key Exclusion

  • Current pregnancy or lactation
  • Glomerular filtration rate less than 50 mL/min/1.73 m²
  • Hyponatremia with serum sodium below 135 mmol/L
  • Angina, significant coronary artery disease, congestive heart failure, or SIADH
  • Uncontrolled hypertension greater than 150/95 mmHg
  • Use of vasopressors, NSAIDs, loop diuretics, or drugs interfering with DDAVP
  • Habitual or psychogenic polydipsia
  • Blood glucose above 200 mg/dL on scan day

NCT07462507

Investigation of Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1

Organization/Sponsor: Washington University School of Medicine


Example patient: A 52-year-old male with newly diagnosed glioblastoma confirmed by MRI and biopsy, no prior radiation therapy, able to provide informed consent and tolerate imaging procedures.

Phase N/A

Interventions

  • Diagnostic Test: Brain MRI
    Summary: Magnetic resonance imaging of the brain with and without contrast agent to enhance visualization (NCI Thesaurus).
  • Radiotracer: [C-11]-CS1P1
    Summary: A PET radiotracer targeting inflammatory markers in brain tissues to assess inflammation in brain cancer and provide insights into disease progression (Summary of Web Search).

Key Inclusion

  • Age ≥ 18 years
  • Clinical, radiographic, or pathological diagnosis of primary or secondary CNS malignancy
  • CNS malignancy not previously treated with radiotherapy
  • Capable of providing written informed consent or has legally authorized representative

Key Exclusion

  • Hypersensitivity to [C-11]-CS1P1 or excipients
  • Prior cranial radiotherapy
  • Contraindications to PET, CT or MRI
  • Severe claustrophobia requiring general anesthesia
  • Currently pregnant or breastfeeding
  • Recent participation in radioactive research studies within 12 months exceeding federal radiation limits

NCT07464925

An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma

Organization/Sponsor: Tetragon Biosciences Ltd


Example patient: A 52-year-old with recurrent Grade 4 glioblastoma after one prior line of temozolomide and radiotherapy, ECOG 1, on stable 4 mg dexamethasone daily, with adequate organ function.

Phase 1

Interventions

  • Drug: GLIX1
    Summary: GLIX1 is a novel small molecule targeting TET2 to induce DNA damage in glioblastoma cells, currently in Phase 1/2a trials for brain cancer (Source: Web Search).

Key Inclusion

  • Adult patients aged ≥18 years
  • Histologically confirmed Grade 3 or Grade 4 glioma
  • Recurrent or progressive disease
  • Maximum of two prior treatment lines
  • At least 3 months since last radiotherapy
  • ECOG performance status 0 or 1
  • Stable or decreasing corticosteroid dose ≤6 mg dexamethasone daily
  • Adequate hematological, liver and renal function

Key Exclusion

  • Known contraindication for gadolinium-based contrast-enhanced MRI
  • Prior invasive malignancy unless complete remission ≥3 years
  • Active or uncontrolled infection or unexplained fever >38°C within 3 days
  • Major surgery or significant traumatic injury within 28 days
  • Receiving investigational products within 4 weeks or 5 half-lives

NCT07438860

Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2- ICG in a Phase 1 Clinical Trial

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 52-year-old with newly diagnosed supratentorial grade IV glioma, Karnofsky score 70%, normal liver and kidney function, planning surgical resection with no prior treatment.

Phase 1

Interventions

  • Procedure: Craniotomy (Standard of Care)
    Summary: Surgical creation of an opening of the skull for tumor resection (NCI Thesaurus).
  • Drug: SBK2-ICG
    Summary: A fluorescent imaging agent that binds to specific tumor markers to enhance visualization of brain tumor edges during surgery, enabling precise surgical margins (Summary of Web Search).

Key Inclusion

  • Suspected or confirmed untreated malignant brain tumors
  • No prior therapies for this disease
  • 18 years of age or older
  • Karnofsky Performance status ≥ 60%
  • Glioma located in supratentorial region
  • Tumor suitable for resection
  • Able to undergo MRI scan

Key Exclusion

  • Pregnant or breast feeding
  • AST, ALT, ALP, or bilirubin >2.5x normal upper limit
  • Plasma creatinine > 2.5 mg/dL
  • Without probable or expected grade IV glioma
  • Not planning surgery on glioma
  • History of allergic reactions to ICG or similar compounds

NCT07470606

Memory RT: Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain

Organization/Sponsor: The University of Texas Health Science Center at San Antonio


Example patient: A 62-year-old woman with metastatic lung cancer to the brain, no prior brain radiation, MMSE score of 24, creatinine clearance of 65 mL/min, scheduled for whole brain radiation therapy with IMRT.

Phase N/A

Interventions

  • Drug: Raloxifene
    Summary: A selective estrogen receptor modulator (SERM) that acts as an estrogen agonist in bone and lipid metabolism and antagonist in breast and endometrium, FDA-approved for osteoporosis treatment and breast cancer risk reduction in postmenopausal women (FDA label, NCI Thesaurus).
  • Drug: Memantine
    Summary: An NMDA receptor antagonist that reduces calcium influx, studied for potential to inhibit brain tumor growth and provide cognitive benefits in brain tumor patients (Summary of Web Search).

Key Inclusion

  • Age ≥ 18 years
  • Undergoing radiation therapy to the brain for solid tumor cancer using IMRT or WBRT
  • Creatinine clearance ≥ 50 mL/min
  • Hepatic impairment not greater than Child-Pugh Score Class A
  • Negative serum pregnancy test for childbearing potential individuals
  • Ability to provide informed written consent in English or Spanish

Key Exclusion

  • History of prior radiotherapy to the brain
  • Life expectancy < 6 months
  • Radiation therapy planned ≤ 5 fractions (SRS, SRT, or 5-fraction whole brain)
  • Contraindications to memantine or raloxifene
  • Unable to undergo MRI scan
  • Known allergy to memantine or raloxifene or their excipients
  • Cognitive failure with MMSE score < 17

NCT06800092

Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment Genomic-based

Organization/Sponsor: The University of Texas Medical Branch, Galveston


Example patient: A 42-year-old premenopausal woman with newly diagnosed ER-positive, HER2-negative breast cancer, BMI 27, no prior chemotherapy, normal blood pressure, and no cognitive impairment history.

Phase N/A

Interventions

  • Drug: Sildenafil
    Summary: Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor that increases cGMP availability, causing smooth muscle relaxation and vasodilation. FDA-approved for pulmonary arterial hypertension, it is being studied here to prevent cancer-related cognitive impairment in breast cancer patients. Sources: FDA label, NCI Thesaurus, Web Search.

Key Inclusion

  • Female
  • Ages 30-50 years
  • Self-reported menses within past 12 months
  • Diagnosis of ER+/HER2- breast cancer
  • Willing and able to provide consent

Key Exclusion

  • Prior history of chemotherapy treatment
  • Prior history of cognitive impairment
  • BMI >30
  • Use of nitrates
  • Systolic BP <90 or >170, diastolic BP <50 or >110
  • Diagnosed neuromuscular or neurovascular disease
  • Untreated thyroid disorder or diabetes
  • MRI incompatible devices or severe claustrophobia

NCT07506239

PNOC042: A Phase 2, Multi-institutional Trial, Evaluating the Efficacy of Laser Interstitial Thermal Therapy (LITT) in Children, Adolescents and Young Adults With Recurrent or Progressive Low-grade Gliomas (LGG)

Organization/Sponsor: University of California, San Francisco


Example patient: A 12-year-old with recurrent thalamic low-grade glioma measuring 4 cm after failing chemotherapy, with Lansky score of 60, stable on dexamethasone, and 14 weeks post-radiation.

Phase 2

Interventions

  • Procedure: Laser Interstitial Thermal Therapy (LITT)
    Summary: A thermal ablation therapy that heats neoplasms with prolonged moderate temperature elevations, resulting in coagulative necrosis in heated tissue (source: NCI Thesaurus).
  • Diagnostic Test: Magnetic resonance imaging (MRI)
    Summary: Diagnostic imaging using magnetic fields and radio waves to create detailed brain images for detecting, monitoring brain cancer, planning treatment, and assessing effectiveness (source: Web Search).
  • Other: Questionnaires
    Summary: Patient-reported outcome assessments targeting cognitive and physical function, quality of life, and symptom management in brain cancer patients (source: Web Search).

Key Inclusion

  • Recurrent or progressive pediatric LGG with at least one prior treatment
  • Histologically confirmed LGG determined suitable for LITT by central review
  • Tumor size up to 5 cm in largest dimension excluding cystic component
  • Age 2 to 25 years
  • Karnofsky ≥50 (>16 years) or Lansky ≥50 (≤16 years)
  • At least 12 weeks since last radiation fraction
  • At least 3 weeks since last chemotherapy (6 weeks for nitrosoureas)
  • Stable or decreasing corticosteroid dose for at least 1 week

Key Exclusion

  • Optic pathway gliomas
  • Spinal tumors
  • Infiltrative brainstem lesions
  • Uncontrolled leptomeningeal disease or extracranial disease
  • Untreated obstructive hydrocephalus or >10mm midline shift
  • Symptomatic intratumoral hemorrhage (Grade 3 or 4)
  • Receiving other investigational agents
  • Ongoing or active uncontrolled infection

NCT07478172

Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults withNeuromuscular Disease

Organization/Sponsor: University of Missouri-Columbia


Example patient: A 52-year-old man with postpolio syndrome and 3/5 lower extremity strength who can stand for 20 minutes with a cane and has medical clearance for exercise.

Phase N/A

Interventions

  • Procedure: Whole-body Electrical Muscle Stimulation Exercise
    Summary: A procedure using small electric impulses to stimulate weak or paralyzed muscles, intended to improve muscle function in neuromuscular disease patients (NCI Thesaurus).

Key Inclusion

  • Age 18 or older
  • Diagnosed with specified neuromuscular conditions including ALS, PLS, SMA, postpolio syndrome, inclusion body myositis, or others
  • Ability to stand for approximately 15 minutes continuously with or without assistive device
  • At least 2+/5 strength in major muscle groups by manual muscle testing
  • Medical clearance to participate in exercise program

Key Exclusion

  • Diagnosed with Becker's, Duchenne's, limb-girdle muscular dystrophy, myotonic dystrophy, or conditions with cardiac involvement
  • Unable to tolerate 15 minutes of continuous standing
  • Presence of pacemaker, metal implants, or implanted medical devices
  • Presence of cochlear implant, deep brain stimulator, or seizure in past 12 months on medication
  • Known pregnancy at screening
  • Use of drugs influencing muscle mass within 6 months including anabolic steroids or growth hormone
  • Additional neurologic conditions affecting motor function like Parkinson's, MS, or stroke history
  • Musculoskeletal surgery in past year

NCT07210632

Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)

Organization/Sponsor: Vanderbilt-Ingram Cancer Center


Example patient: A 52-year-old man with MRI findings suspicious for glioblastoma, scheduled for surgical resection, with normal organ function and no autoimmune conditions or recent infections.

Phase N/A

Interventions

  • Biological: Nivolumab-IRDye800
    Summary: Fluorescently labeled nivolumab conjugated with IRDye800 for intraoperative imaging; blocks PD-1 receptor to enhance T-cell immune response against high grade glioma while enabling real-time tumor visualization during surgery (FDA label, Web Search).
  • Biological: Nivolumab
    Summary: Fully human IgG4 monoclonal antibody that blocks PD-1 receptor, preventing binding of PD-L1/PD-L2 ligands, thereby activating T-cells and cell-mediated immune responses against tumor cells (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years
  • Imaging highly suspicious for high grade glioma
  • Surgical craniotomy planned as standard of care
  • Adequate hematologic and end-organ function
  • Negative hepatitis B surface antigen at screening

Key Exclusion

  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis or pneumonitis
  • Significant cardiovascular disease within 3 months
  • Chronic systemic immunosuppressive medication >10 mg/day prednisone equivalent
  • Prior allogeneic stem cell or solid organ transplantation
  • Severe unresolved infection within 4 weeks
  • Pregnant or breastfeeding
  • Baseline QTcF interval > 480 milliseconds

NCT07540572

An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer

Organization/Sponsor: IDEAYA Biosciences


Example patient: A 58-year-old postmenopausal woman with metastatic ER-positive, HER2-negative breast cancer who progressed after treatment with letrozole and palbociclib, with ECOG status 1 and adequate organ function.

Phase 1

Interventions

  • Drug: IDE574
    Summary: IDE574 is a dual inhibitor of KAT6/7 enzymes that blocks specific histone acetyltransferases to inhibit cancer growth in breast cancer and other solid tumors, currently in Phase 1 trials (Web Search).
  • Drug: Fulvestrant injection
    Summary: Fulvestrant is an estrogen receptor antagonist that degrades estrogen receptors to block estrogen signaling in hormone receptor-positive, HER2-negative advanced breast cancer, administered intramuscularly (FDA label).

Key Inclusion

  • Advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, or MSS colorectal adenocarcinoma
  • Progressed after at least one line of standard therapy or intolerant to effective therapies
  • ER+, HER2- breast cancer progressed after endocrine therapy and CDK4/6 inhibitor
  • ECOG performance status ≤1
  • Adequate bone marrow, renal and liver function
  • Life expectancy >3 months
  • Archival tissue sample available for testing

Key Exclusion

  • Known symptomatic brain metastases or leptomeningeal metastasis
  • Known primary CNS malignancy or other malignancies within 2 years
  • Impairment of GI function that may alter drug absorption
  • Active liver or biliary disease
  • Active uncontrolled bacterial, fungal, or viral infection
  • Clinically significant cardiac abnormalities or blood clotting events within 6 months
  • Prior irradiation to >25% of bone marrow
  • Known hypersensitivity to IDE574, fulvestrant, or their excipients