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High Grade GliomaPhase 1NCT05362409

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma

A Phase 1 study testing 5 Aminolevulinic Acid and CV01-delivered ultrasound in people with High Grade Glioma, run by Alpheus Medical, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High Grade Glioma
What is being tested?
5 Aminolevulinic Acid and CV01-delivered ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
3 sitesUnited States
Study dates
29 Jun 2022to 3 Feb 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements
  • ≥ 18 years of age
  • WHO performance status of ≤ 2 at screening
  • Part A: Previous histopathologically confirmed diagnosis of high-grade glioma and radiographic evidence of recurrence after prior therapy with radiotherapy. Eligible histologies include (according to WHO classification 2021):
  • Astrocytoma, WHO grade 3 and 4 (including subtypes)
  • Oligodendroglioma WHO grade 3 (including subtypes)
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  • Parts B and C: Previous histopathologically confirmed diagnosis of glioblastoma and radiographic evidence of recurrence after prior therapy with radiotherapy. While Part A may include patients with any type of HGG and any number of recurrences, Parts B and C are restricted to patients with glioblastoma experiencing first recurrence.
  • Unifocal or multifocal tumor confined to the supratentorial compartment
  • Interval since last anti-cancer therapy relative to first 5-ALA treatment, as detailed below
  • End of radiotherapy >12 weeks (including skin-directed radiation for skin cancer),
  • Last cytotoxic chemotherapy (4 weeks, if prior nitrosureas 6 weeks).
  • Last biological therapy, i. If bevacizumab ≥ 6 weeks ii. If other monoclonal antibody, e.g., immune checkpoint inhibitor > 3 weeks iii. If tyrosine kinase inhibitor or other small molecule > 2 weeks
  • Any other investigational agent(s) ≥ 30 days or 5 half-lives, whichever is longer
  • Photodynamic therapy for skin cancer or actinic keratoses ≥ 12 weeks
  • Any toxicity attributable to prior anti-cancer therapy must be resolved to the patient's baseline level or ≤ Grade 1 (except alopecia).
  • Adequate bone marrow and organ function, defined by the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
  • Platelet count ≥ 100,000 cells/mm3
  • Hemoglobin (Hgb) ≥ 8 g/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN (unless Gilbert's syndrome, then patients may be eligible if total serum bilirubin is ≤ 3.0 x ULN or direct bilirubin is ≤ 1.5 x ULN)
  • Creatinine clearance (CrCL) as estimated by Cockcroft-Gault equation of ≥ 50 mL/min
  • Adequate coagulation function defined as PT (prothrombin time)/PTT (partial thromboplastin time) within normal institutional values
  • Males or non-pregnant, non-lactating females who are postmenopausal, surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation or hysterectomy), or who agree to use effective contraceptive methods as defined by the protocol during the study and for 30 days after the last investigational treatment, see Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) concentration ≥ 40 IU/L, or at least 6 weeks following surgical menopause (bilateral oophorectomy).
  • Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to first 5-ALA administration
  • Agreement to adhere to Lifestyle Considerations throughout study duration
  • Part C, Surgical group only: Tumor resection surgery is clinically indicated and planned for the patient, regardless of study participation

Who cannot join

  • Primary infratentorial or brainstem tumors
  • Primary spinal cord tumors
  • Bihemispheric disease (enhancing or non-enhancing) or tumors that involve the bilateral corpus callosum
  • Women who are pregnant or breastfeeding
  • Inability to undergo MRI or receive gadolinium (Gd)-based contrast agents
  • Hypersensitivity to 5-ALA or porphyrins
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  • Average skull thickness at the treatment field > 10 mm as assessed by Alpheus Medical.
  • The treatment field is defined as the various locations on the head where the transducer will be coupled to the patient. The average skull thickness at each treatment field will be determined by Alpheus Medical through post-processing the thin cut head computed tomography (CT) (without contrast). The patient's CT scan must be provided to Alpheus Medical for evaluation as part of the Screening and Enrollment process.
  • Hemorrhagic or ischemic stroke (including transient ischemic attacks) and central nervous system bleeding in the preceding 6 months that are not related to glioma surgery. History of prior intratumoral bleeding is not an exclusion criterion; however, patients with a history of prior intratumoral or intracranial bleeding will undergo a non-contrast head CT to exclude acute bleeding.
  • Patients who have clinically significant edema requiring urgent intervention (e.g., surgery, initiation of steroids, escalating doses of steroids).
  • Patients with progressive and rapid clinical deterioration that, in the opinion of the investigator, is likely to worsen during the first cycle of treatment or in the peri-operative interval (in the surgical cohort)
  • Cumulative prior RT dose > 64 Gy
  • Acute or chronic types of porphyria
  • Gastrointestinal disorder that negatively affects absorption
  • Known active hepatitis B or C (Note: testing is not required)
  • Known human immunodeficiency virus (HIV) infection (Note: testing is not required)
  • Unable to avoid phototoxic drugs (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones, and tetracyclines) for 24 hours prior to and following 5-ALA administration
  • Any other concurrent severe or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, cardiac disease, clinically significant psychiatric or neurological disorder, active or uncontrolled infection)
  • Patient has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Northwell

    Lake Success, New York, 11042

  • Washington University School of Medicine in St.Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1 Multi-center Clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy(SDT) in Patients With Recurrent High Grade Glioma (HGG)

A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG).

Read the detailed description

High-grade gliomas are the most commonly occurring primary CNS tumors in adults. The investigational product in this clinical study is a drug-device combination product consisting of 5-ALA HCl oral solution and the CV01 ultrasound delivery device. 5-ALA will be administered as a sonosensitizer prior to CV01-delivered ultrasound and will be re-administered every 4 weeks prior to CV01 ultrasound delivery. The CV01 device will deliver non-ablative, low-intensity ultrasound to deep regions of the brain to induce apoptosis of cancer cells. Part A will focus on duration escalation and determining the recommended duration of CV01 delivered ultrasound. Part B will further explore safety and tolerability through cohort expansion at the recommended duration of CV01 delivered ultrasound. Part C will include an exploratory surgical cohort at the recommended duration of CV01 delivered ultrasound. This FIH study will evaluate escalating durations of ultrasound delivery with CV01 and will enroll up to 48 patients.

Being tested
5 Aminolevulinic Acid, CV01-delivered ultrasound
Keywords
Cancer, Brain Cancer, Sonodynamic, Glioma, High Grade Glioma (HGG), Sonodynamic therapy (SDT), Glioblastoma
Medical subject headings
Glioma, Neoplasms, Brain Neoplasms, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5 Aminolevulinic AcidDrug

    Also called 5-ALA, Gleolan

    5-aminolevulinic acid [5-ALA] administered orally 20 mg/kg every 4 weeks

  • CV01-delivered ultrasoundDevice

    CV01-delivered ultrasound every 4 weeks

Study groups in NCT05362409
Study groupRoleWhat they receive
5-ALA with CV01Experimental5-aminolevulinic acid [5-ALA] with CV01-delivered ultrasound
Receives: Drug: 5 Aminolevulinic Acid; Device: CV01-delivered ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (Safety and Tolerability)

    Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)

    Measured: 12 Months

  2. To determine the Maximum Tolerable Duration (MTDu)

    The MTDu is defined as the highest duration at which fewer than 1/3 of patients experience a Duration limited toxicity

    Measured: 12 Months

Secondary outcomes (4)

  1. Assessment of Overall response rate (ORR)

    ORR assessed by RANO criteria

    Measured: 12 Months

  2. Assessment of Duration of Response (DoR)

    Measured: 12 Months

  3. Assessment of Overall survival (OS)

    Measured: 12 Months

  4. Assessment of Progression free survival (PFS)

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start29 Jun 2022
  3. Primary completion3 Dec 2024
  4. Study completion3 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Part A will include cohorts at escalating duration of sonication. Parts B and C will include the recommended duration as determined in Part A.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05362409
Sponsor's protocol ID
CV01-101
Status last verified
Jan 2025
First submitted
2 May 2022
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 5 Aminolevulinic Acid and CV01-delivered ultrasound in people with High Grade Glioma, run by Alpheus Medical, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (Safety and Tolerability) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05362409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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