Glioblastoma Multiforme of BrainPhase 1NCT05363826
Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®
A Phase 1 study testing photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) in people with Glioblastoma Multiforme of Brain and Glioma, Sarcomatous, run by Photolitec LLC at 1 site in United States.
Trial summary
This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective. Photodynamic Therapy (PDT) combines light and a photosensitizer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme of Brain, Glioma, Sarcomatous
- What is being tested?
- photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to May 2026
- 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
- Age ≥ 18years.
- Subject has a Karnofsky performance status ≥ 70 (i.e. the subject must be able to care for himself/herself with occasional help from others; refer to Appendix G).
- Subject has pathologically confirmed diagnosis of glioblastoma or gliosarcoma.
- Subject has recurrent or progressive tumor following standard therapy.
- Subject has recurrent cerebral tumor that in the opinion of the treating neurosurgeon is surgically resectable.
- Subject has the following clinical laboratory values obtained within 14 days prior to registration:
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- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L Hemoglobin (Hgb) > 9.0 g/dL Plasma total bilirubin: ≤ 1.5 x ULN ALT and AST ≤ 2.0 x ULN Creatinine clearance >60 WBC ≥ 4000 INR ≤ 1.1 x ULN
- Subject will have been off all anticoagulant therapy (e.g., warfarin, heparin, enoxaparin, rivaroxaban, apixaban, aspirin) for at least 5 days before surgery and Photobac® infusion.
- No active bleeding or pathological condition that in the judgement of the principal investigator carries a high risk of bleeding
- Subject of child-bearing potential "agrees to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and have a negative pregnancy test prior to starting study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Subject has completed radiation therapy (RT) and temozolomide (TMZ) for the treatment of their glioblastoma or gliosarcoma at least 30 days prior to entry
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Who cannot join
- Subject has serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the subject to receive the treatment outlined in this protocol with reasonable safety.
- Subject is pregnant or breast-feeding.
- Subject has latex allergy.
- Subject has received another chemotherapeutic or investigational agent in addition to radiation therapy and concomitant temozolomide treatment within 30 days of planned PDT.
- Subject has persistent toxicity of prior therapy.
- Subject has gliomatosis cerebri.
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- Subject has cerebral tumor that in the opinion of the treating neurosurgeon is unresectable.
- Subject has brainstem, spinal cord or cerebellar involvement by tumor.
- Subject has known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness.
- Subject has contraindication to MRI scans or gadolinium contrast agent.
- Subject has history of porphyria, hypersensitivity to porphyrin or porphyrin-like compounds or any other abnormal skin photosensitivity.
- Subject is unwilling or unable to follow protocol requirements.
- Subject has any condition which in the Investigator's opinion makes the subject unsuitable to receive the study drug. Must be reported.
- Subject has any condition which in the treating neurosurgeon's opinion makes the subject unsuitable to undergo craniotomy for tumor resection.
- Subject has received an investigational agent within 30 days prior to planned PDT.
- Subject has midline shift > 1 cm.
- Subject is unable to give consent to participate in the study.
- Subject has a QTC interval > 470 milliseconds (CTCAE grade 1) using Frederica's QT correction formula.
- Subject has serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the subject to tolerate the added hour o anesthesia outlined in this protocol with reasonable safety.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer
Buffalo, New York, 14263
Robert Fenstermaker, MD, 716-845-3154, Robert.Fenstermaker@RoswellPark.org
Ravindra Pandey, PhD, 1 800-767-9355, Ravindra.Pandey@RoswellPark.org
About this study
Official title: Phase I Study of the Safety of Intracavitary Photodynamic Therapy (PDT) of the Brain Bordering Resected Recurrent Glioblastoma or Gliosarcoma Using Intravenous Photobac® and a Balloon Light Applicator
This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective.
Photodynamic Therapy (PDT) combines light and a photosensitizer. PDT has been used to treat a variety of cancers with varying degrees of success.
Read more
For the past thirty years Photolitec has been working to develop a treatment for glioblastoma or gliosarcoma using light and a photosensitizer. Photolitec's scientists were looking for a photosensitizer that:
- has no significant systemic toxicity apart from some temporary skin photosensitivity,
- crosses the blood brain barrier,
- accumulates to a high level in glioblastoma and minimally in the brain,
- is activated by the wavelength of light that penetrates most deeply into the brain,
- minimizes any temporary skin photosensitivity.
Preliminary testing indicates the Photolitec team has achieved these five goals. Photolitec is now able to offer a clinical trial based on the results of this work.
Read the detailed description
Twenty four hours before surgery the patient will receive an intravenous injection of Photobac®. This will make the brain tumor sensitive to light. Lighting up the brain using a low power near infrared laser will kill cells that contain Photobac®.
Photobac® crosses the blood brain barrier. Compared to the brain at 24 hours after injection, the tumor holds significantly more Photobac®. This Selective retention by tumors is the reason PDT has proved a valuable weapon against other types of tumors.
Once the surgeon has removed the tumor as completely as possible, the brain that bordered the tumor will be illuminated with near infrared light from a low power laser. This will destroy tumor cells hiding deep in the brain. Such cells cause tumor recurrence.
The light treatment will add about one hour to the surgery. The Patient will be asleep during this procedure. The patient will receive standard post-surgical care during recovery.
- Being tested
- photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)
- Keywords
- Photochemo Therapy, Photo Dynamic Therapy, PDT
- Medical subject headings
- Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)Combination product
Also called Photobac® PDT
Intravenous injection of Photobac® 24 hours before surgical removal of recurrent GBMF.
Immediately after resection, the cavity will be treated with 50 joules/ square cm of 787nm light. This treatment will add a maximum of 50 minutes to the surgery
| Study group | Role | What they receive |
|---|---|---|
| Photochemotherapy as an adjuvant to surgical resection of glioblastoma | Experimental | 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester (Photobac®) is injected 24 hours prior to surgical resection of a recurrent Glioblastoma or gliosarcoma. Immediately following the resection the cavity is treated with 50 joules/ square cm of 787 nm light .The drug dose is escalated using three patient cohorts until a dose limiting toxicity is reached or the upper limit of the 8 step escalation is reached. Receives: Combination Product: photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity will be measured using CTCAE v5 ( Common Terminology Criteria for Adverse Events
•A dose limiting toxicity (DLT)will stop the escalation. A DLT includes all greater than or equal to grade 3 non-hematological toxicities and all greater than or equal to grade 4 hematological toxicities per CTCAE v 5.0
Measured: .up to 24 hours
The Maximum Tolerable drug Dose (MTD) will be determined by evaluating the safety of a fixed light dose and escalating drug dose
The MTD will be determined by first discovering the dose limiting toxicity ( DLT). As defined above and following the procedure for determining the MTD from the DLT found in the protocol. It is expected that the DLT may be acute neurotoxicity caused by brain swelling.
Measured: up to one week
Measure the Photobac concentration in blood.
Photobac® concentration in blood will be measured by drawing blood at various time points. The blood will be spun down and the concentration in the serum measured spectroscopically. Non-linear regression will be used to determine the clearance rate constants from these data.
Measured: up to12 weeks
Measure Photobac® concentration in tumor tissue removed during resection and in the bed of the tumor both before and after ligh treatment.
The tissue samples will be subject to chemical extraction of the Photobac®. Photobac® concentration in the extract will be measured spectroscopically.
Measured: 1 hour
Time of Progression Free Survival
The duration of progression free survival will be assessed by a Roswell neuroradiologist using RANO criteria.
Measured: up t o18 months
Overall survival from time of diagnosis
Patients will be followed for the duration of the study and if possible until death.
Measured: up to 18 months
Secondary outcomes (3)
Duration and severity of skin photosensitivity t osimulated sunlight .
If the patient's condition permits, a solar simulator will be used to assess the patient's skin photosensitivity .The severity and duration of sensitivity will be assessed using the Draize scale. The Draize scale ranges from zero indicating no reaction to 4 indicating a severe reaction. Two numbers will be reported one for erythema and the second for edema
Measured: 1 week
Assess patterns of treatment failure for any association with the drug dose
Duration of survival and progression free survival will be examined for evidence of a Photobac® dose dependant response.
Measured: up to 15 months.
Measure Stat 3 Crosslinking as a quantitative marker of singlet oxygen tissue damage
The samples of tissue taken from the tumor bed will be assayed for the degree of stat 3 crosslinking. Stat3 crosslinking is caused by singlet oxygen damage and is expected correlate with the PDT dose.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start11 Apr 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma Multiforme of BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Model description
- This is a phase I Drug study of the photochemotherapy drug Methyl bacteriopurpurinimide Bacteriopurpurinimide-methyl ester (registered trade name Photobac®) in adult subjects with recurrent diagnosed glioblastoma or gliosarcoma. We are evaluating the safety of this photosensitizing drug in an 8 step dose escalation with 3 patients per step and a fixed light dose (50 joules / square centimeter) by way of intraoperative cavitary photodynamic therapy using a balloon and spherical diffuser to deliver the light.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Photolitec LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roswell Park Cancer Institute, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William R Potter, MA, Principal investigator, Photolitec LLCRobert Fenstermaker, MD, Principal investigator, Roswell Park Dept of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363826
- Sponsor's protocol ID
- 14598
- Other IDs
- 4R44CA247127-02
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Patel N, Pera P, Joshi P, Dukh M, Tabaczynski WA, Siters KE, Kryman M, Cheruku RR, Durrani F, Missert JR, Watson R, Ohulchanskyy TY, Tracy EC, Baumann H, Pandey RK. Highly Effective Dual-Function Near-Infrared (NIR) Photosensitizer for Fluorescence Imaging and Photodynamic Therapy (PDT) of Cancer. J Med Chem. 2016 Nov 10;59(21):9774-9787. doi: 10.1021/acs.jmedchem.6b00890. Epub 2016 Oct 31.
PubMed 27749069
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety of Intracavitary Photodynamic Therapy (PDT) of the Brain Bordering Resected Recurrent Glioblastoma or Gliosarcoma Using Intravenous Photobac® and a Balloon Light Applicator
- ClinicalTrials.gov ID
- NCT05363826
- Acronym / sponsor ID
- 14598
- Keywords
- Photochemo Therapy, Photo Dynamic Therapy, PDT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Photolitec LLCIndustry (pharma, biotech, devices)
- Collaborators
- Roswell Park Cancer Institute, National Cancer Institute (NCI)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective.
Photodynamic Therapy (PDT) combines light and a photosensitizer. PDT has been used to treat a variety of cancers with varying degrees of success.
For the past thirty years Photolitec has been working to develop a treatment for glioblastoma or gliosarcoma using light and a photosensitizer. Photolitec's scientists were looking for a photosensitizer that:
- has no significant systemic toxicity apart from some temporary skin photosensitivity,
- crosses the blood brain barrier,
- accumulates to a high level in glioblastoma and minimally in the brain,
- is activated by the wavelength of light that penetrates most deeply into the brain,
- minimizes any temporary skin photosensitivity.
Preliminary testing indicates the Photolitec team has achieved these five goals. Photolitec is now able to offer a clinical trial based on the results of this work.
Detailed description
Twenty four hours before surgery the patient will receive an intravenous injection of Photobac®. This will make the brain tumor sensitive to light. Lighting up the brain using a low power near infrared laser will kill cells that contain Photobac®.
Photobac® crosses the blood brain barrier. Compared to the brain at 24 hours after injection, the tumor holds significantly more Photobac®. This Selective retention by tumors is the reason PDT has proved a valuable weapon against other types of tumors.
Once the surgeon has removed the tumor as completely as possible, the brain that bordered the tumor will be illuminated with near infrared light from a low power laser. This will destroy tumor cells hiding deep in the brain. Such cells cause tumor recurrence.
The light treatment will add about one hour to the surgery. The Patient will be asleep during this procedure. The patient will receive standard post-surgical care during recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase I Drug study of the photochemotherapy drug Methyl bacteriopurpurinimide Bacteriopurpurinimide-methyl ester (registered trade name Photobac®) in adult subjects with recurrent diagnosed glioblastoma or gliosarcoma. We are evaluating the safety of this photosensitizing drug in an 8 step dose escalation with 3 patients per step and a fixed light dose (50 joules / square centimeter) by way of intraoperative cavitary photodynamic therapy using a balloon and spherical diffuser to deliver the light.
| Arm | Type | Receives |
|---|---|---|
| Photochemotherapy as an adjuvant to surgical resection of glioblastoma | Experimental | Combination Product: photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester (Photobac®) is injected 24 hours prior to surgical resection of a recurrent Glioblastoma or gliosarcoma. Immediately following the resection the cavity is treated with 50 joules/ square cm of 787 nm light .The drug dose is escalated using three patient cohorts until a dose limiting toxicity is reached or the upper limit of the 8 step escalation is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18years.
- Subject has a Karnofsky performance status ≥ 70 (i.e. the subject must be able to care for himself/herself with occasional help from others; refer to Appendix G).
- Subject has pathologically confirmed diagnosis of glioblastoma or gliosarcoma.
- Subject has recurrent or progressive tumor following standard therapy.
- Subject has recurrent cerebral tumor that in the opinion of the treating neurosurgeon is surgically resectable.
Key exclusion criteria (19 listed)
- Subject has serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the subject to receive the treatment outlined in this protocol with reasonable safety.
- Subject is pregnant or breast-feeding.
- Subject has latex allergy.
- Subject has received another chemotherapeutic or investigational agent in addition to radiation therapy and concomitant temozolomide treatment within 30 days of planned PDT.
- Subject has persistent toxicity of prior therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)Also: Photobac® PDTIntravenous injection of Photobac® 24 hours before surgical removal of recurrent GBMF. Immediately after resection, the cavity will be treated with 50 joules/ square cm of 787nm light. This treatment will add a maximum of 50 minutes to the surgery | Combination product | Photochemotherapy as an adjuvant to surgical resection of glioblastoma |
Primary outcome
Toxicity will be measured using CTCAE v5 ( Common Terminology Criteria for Adverse Events
Time frame: .up to 24 hours
•A dose limiting toxicity (DLT)will stop the escalation. A DLT includes all greater than or equal to grade 3 non-hematological toxicities and all greater than or equal to grade 4 hematological toxicities per CTCAE v 5.0
The Maximum Tolerable drug Dose (MTD) will be determined by evaluating the safety of a fixed light dose and escalating drug dose
Time frame: up to one week
The MTD will be determined by first discovering the dose limiting toxicity ( DLT). As defined above and following the procedure for determining the MTD from the DLT found in the protocol. It is expected that the DLT may be acute neurotoxicity caused by brain swelling.
Measure the Photobac concentration in blood.
Time frame: up to12 weeks
Photobac® concentration in blood will be measured by drawing blood at various time points. The blood will be spun down and the concentration in the serum measured spectroscopically. Non-linear regression will be used to determine the clearance rate constants from these data.
Measure Photobac® concentration in tumor tissue removed during resection and in the bed of the tumor both before and after ligh treatment.
Time frame: 1 hour
The tissue samples will be subject to chemical extraction of the Photobac®. Photobac® concentration in the extract will be measured spectroscopically.
Time of Progression Free Survival
Time frame: up t o18 months
The duration of progression free survival will be assessed by a Roswell neuroradiologist using RANO criteria.
Overall survival from time of diagnosis
Time frame: up to 18 months
Patients will be followed for the duration of the study and if possible until death.
3 secondary outcomes
Duration and severity of skin photosensitivity t osimulated sunlight .
Time frame: 1 week
Assess patterns of treatment failure for any association with the drug dose
Time frame: up to 15 months.
Measure Stat 3 Crosslinking as a quantitative marker of singlet oxygen tissue damage
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 27749069Patel N, Pera P, Joshi P, Dukh M, Tabaczynski WA, Siters KE, Kryman M, Cheruku RR, Durrani F, Missert JR, Watson R, Ohulchanskyy TY, Tracy EC, Baumann H, Pandey RK. Highly Effective Dual-Function Near-Infrared (NIR) Photosensitizer for Fluorescence Imaging and Photodynamic Therapy (PDT) of Cancer. J Med Chem. 2016 Nov 10;59(21):9774-9787. doi: 10.1021/acs.jmedchem.6b00890. Epub 2016 Oct 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William R Potter, MA principal investigator
Photolitec LLC
Robert Fenstermaker, MD principal investigator
Roswell Park Dept of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®) in people with Glioblastoma Multiforme of Brain and Glioma, Sarcomatous, run by Photolitec LLC at 1 site 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 13 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ravindra Pandey, PhD (800-767-9355 ext. 3203, Ravindra.Pandey@photolitec.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity will be measured using CTCAE v5 ( Common Terminology Criteria for Adverse Events (time frame: .up to 24 hours). The study lists 6 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 NCT05363826, which also lists 1 linked publication.
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 13 Apr 2023.