High-Grade GliomaEarly Phase 1NCT06829173
Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas
A Early Phase 1 study testing XRD-0394, Radiation Therapy and Surgical Resection in people with High-Grade Glioma, run by NYU Langone Health at 1 site in United States.
Trial summary
This is an open-label, dose-finding study of XRD-0394 in subjects with newly diagnosed and recurrent high grade gliomas receiving radiation therapy, with and without concurrent temozolomide based on O6-Methylguanine-DNA methyltransferase (MGMT) status for patients with newly diagnosed high grade gliomas. 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?
- XRD-0394, Radiation Therapy and Surgical Resection
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to May 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Willing and able to provide written informed consent.
- ≥18 years of age.
- For Cohorts A and B, radiographic diagnosis of high-grade glioma that is then confirmed with biopsy. Patients with established histologic diagnosis of high-grade glioma is able to enroll on the study without repeating biopsy.
- For Cohort C, histologic diagnosis of high-grade glioma is required to enroll on the study.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Subjects must have adequate liver and kidney function, defined as: Liver transaminase levels ≤2.5 × the upper limit of normal (ULN); total bilirubin ≤1.5 × ULN, except in subjects with Gilbert's Disease in whom total bilirubin ≤5 × ULN is allowed; OR Creatinine clearance ≥60 mL/min measured from a 24-hour urine collection or calculated based on the Cockcroft-Gault formula.
Show all 10Show fewer
- Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy. Female subjects of childbearing potential who are undergoing RT or who are partners to male subjects in the study should avoid sexual activity or use a highly effective method of birth control during sexual intercourse. Acceptable, highly effective methods of birth control include intrauterine device (IUD)/intrauterine hormone releasing system (IUS), bilateral tube occlusion, vasectomized partner, combined (estrogen and progesterone containing) or progesterone-only hormonal contraceptives (oral, intravaginal, transdermal, injectable).
- Subjects receiving anti-glioma therapy are eligible if treatment can be held 14 days before the first XRD-0394 dose and resume a minimum of 5 days after completion of XRD-0394 (Cohort C only).
- Patient with recurrent tumor amendable to reirradiation and is at least 3 months from end of prior brain radiation therapy (Cohort C only)
- Subjects taking glucocorticoids before and during protocol treatment period will be included per the discretion of the investigator. Intake should be minimized before and during treatment.
Who cannot join
- Prior radiotherapy to the same region or prior anti-glioma systemic therapy in patients with newly diagnosed HGG (Cohorts A and B, not applicable for Cohort C)
- Subjects with bone marrow impairment as evidenced by hemoglobin <8.0 g/dL, neutrophil count <1.5 × 109/L, or platelets <100 × 109/L.
- History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption of XRD-0394, use of percutaneous endoscopic gastrostomy (PEG) tubes.
- Significant cardiac conduction abnormalities, including a history of long corrected QT (QTc) interval syndrome (>450 msec per Fridericia's formula) and/or pacemaker, or impaired cardiovascular function such as New York Heart Association classification >2 at screening.
- Participation in another investigational study of an unapproved drug or device or treatment with another ATM, deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK), or ataxia-telangiectasia and Rad3-related (ATR) inhibitor within 28 days of the first dose of XRD-0394.
- Subjects who are pregnant or breast-feeding.
Show all 10Show fewer
- Subjects with a QTc interval >450 msec (calculated using Fridericia's QT correction formula) at screening.
- Contraindication to temozolomide (Cohort A only)
- Severe headache, rapidly progressive neurologic decline, objective neurologic manifestations of uncal herniation, depressed level of consciousness
- Subjects receiving treatment with any drug that is a strong inhibitor or inducer of CYP3A4 enzyme activity or an inhibitor of BCRP within a minimum of 5 half- lives or 14 days prior to screening or during study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Trials NYU Langone contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Phase 0/I Study to Assess the Safety and Tolerability of XRD-0394 in Combination With Radiation Therapy in Patients With High Grade Gliomas
This is an open-label, dose-finding study of XRD-0394 in subjects with newly diagnosed and recurrent high grade gliomas receiving radiation therapy, with and without concurrent temozolomide based on O6-Methylguanine-DNA methyltransferase (MGMT) status for patients with newly diagnosed high grade gliomas.
- Conditions
- High-Grade Glioma
- Being tested
- XRD-0394, Radiation Therapy, Surgical Resection
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XRD-0394Drug
Administered orally; small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and DNA-PK.
Radiation TherapyRadiation
For Cohort A and Cohort B, the neoadjuvant "boost" radiation dose is 1400cGy delivered over 7 fractions, and the adjuvant radiation dose is 5000cGy delivered over 25 fractions for a total dose of 6400cGy over 32 fractions, accounting for the treatment break between boost and adjuvant RT.
For Cohort C, the radiation dose is 3500cGy delivered over 10 fractions.
Surgical ResectionProcedure or surgery
Resection of tumor tissue.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Surgery Dose-Escalation | Experimental | Patients with newly-diagnosed high grade gliomas (HGG) receiving neoadjuvant radiation therapy (RT) prior to surgical resection will be enrolled in the Pre-Surgical Dose-Escalation arm, at one of two dose levels:
Participants enrolled at Pre-Surgical Dose Level 1 (DL1) will receive 160mg daily XRD-0394 on the days of radiation therapy before surgery.
Participants enrolled at Pre-Surgery Dose Level 2 (DL2) will receive 300mg daily XRD-0394 on the days of radiation therapy before surgery.
All patients enrolled in the pre-surgical dose escalation portion of the study will receive DL1 in the post-surgical dose-escalation portion of the study, but will not be enrolled in the Post-Surgery Dose Escalation arms for purpose of analysis. Receives: Drug: XRD-0394; Radiation: Radiation Therapy; Procedure: Surgical Resection |
| Cohort A: Post-Surgery Dose Escalation | Experimental | MGMT-methylated patients will be enrolled in Cohort A following surgical resection.
Participants enrolled at Post-Surgery Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy.
Participants enrolled at Post-Surgery Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy.
Participants enrolled at Post-Surgery Dose-Level 3 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Receives: Drug: XRD-0394; Radiation: Radiation Therapy; Procedure: Surgical Resection |
| Cohort B: Post-Surgery Dose Escalation | Experimental | MGMT-unmethylated patients will be enrolled in Cohort B following surgical resection.
Participants enrolled at Post-Surgery Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy.
Participants enrolled at Post-Surgery Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy.
Participants enrolled at Post-Surgery Dose-Level 2 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Receives: Drug: XRD-0394; Radiation: Radiation Therapy; Procedure: Surgical Resection |
| Cohort C: Dose-Escalation (No Surgery) | Experimental | Patients with recurrent high-grade glioma (HGG) will be enrolled in Cohort C.
Participants enrolled at Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy.
Participants enrolled at Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy.
Participants enrolled at Dose-Level 2 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Receives: Drug: XRD-0394; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience Dose-Limiting Toxicities (DLTs)
Assessed among patients who receive at least one dose of the study drug and are evaluated for dose-limiting toxicities (DLTs).
Measured: End of DLT Monitoring Period (Pre-surgical dose-escalation: Day 8; Cohort C: Day 44; Cohorts A & B: Day 108)
Secondary outcomes (5)
Progression-Free Survival (PFS)
Assessed among Cohorts A, B, and C only. Defined as the time from the start of treatment until the first documented disease progression or death.
Measured: Up to Year 3 Post-Enrollment
Overall Survival (OS)
Assessed among Cohorts A, B, and C only. Defined as the time from treatment initiation until death from any cause.
Measured: Up to Year 3 Post-Enrollment
Maximum Concentration (Cmax) of XRD-0394 in Resected Tumor Tissue
Assessed among Pre-Surgical Dose-Escalation participants only.
Measured: Day 8 (Day of Surgery)
Area Under the Curve (AUC) of XRD-0394 in Resected Tumor Tissue
Assessed among Pre-Surgical Dose-Escalation participants only.
Measured: Day 8 (Day of Surgery)
Time to Maximum Concentration (Tmax) of XRD-0394 in Resected Tumor Tissue
Assessed among Pre-Surgical Dose-Escalation participants only.
Measured: Day 8 (Day of Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start5 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade GliomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Yang, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829173
- Sponsor's protocol ID
- 24-01715
- Status last verified
- Dec 2025
- First submitted
- 11 Feb 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jonathan.Yang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0/I Study to Assess the Safety and Tolerability of XRD-0394 in Combination With Radiation Therapy in Patients With High Grade Gliomas
- ClinicalTrials.gov ID
- NCT06829173
- Acronym / sponsor ID
- 24-01715
- Conditions
- High-Grade Glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 17 Feb 2025 (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 is an open-label, dose-finding study of XRD-0394 in subjects with newly diagnosed and recurrent high grade gliomas receiving radiation therapy, with and without concurrent temozolomide based on O6-Methylguanine-DNA methyltransferase (MGMT) status for patients with newly diagnosed high grade gliomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-Surgery Dose-Escalation | Experimental | Drug: XRD-0394, Radiation: Radiation Therapy, Procedure: Surgical ResectionPatients with newly-diagnosed high grade gliomas (HGG) receiving neoadjuvant radiation therapy (RT) prior to surgical resection will be enrolled in the Pre-Surgical Dose-Escalation arm, at one of two dose levels: Participants enrolled at Pre-Surgical Dose Level 1 (DL1) will receive 160mg daily XRD-0394 on the days of radiation therapy before surgery. Participants enrolled at Pre-Surgery Dose Level 2 (DL2) will receive 300mg daily XRD-0394 on the days of radiation therapy before surgery. All patients enrolled in the pre-surgical dose escalation portion of the study will receive DL1 in the post-surgical dose-escalation portion of the study, but will not be enrolled in the Post-Surgery Dose Escalation arms for purpose of analysis. |
| Cohort A: Post-Surgery Dose Escalation | Experimental | Drug: XRD-0394, Radiation: Radiation Therapy, Procedure: Surgical ResectionMGMT-methylated patients will be enrolled in Cohort A following surgical resection. Participants enrolled at Post-Surgery Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy. Participants enrolled at Post-Surgery Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Participants enrolled at Post-Surgery Dose-Level 3 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. |
| Cohort B: Post-Surgery Dose Escalation | Experimental | Drug: XRD-0394, Radiation: Radiation Therapy, Procedure: Surgical ResectionMGMT-unmethylated patients will be enrolled in Cohort B following surgical resection. Participants enrolled at Post-Surgery Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy. Participants enrolled at Post-Surgery Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Participants enrolled at Post-Surgery Dose-Level 2 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. |
| Cohort C: Dose-Escalation (No Surgery) | Experimental | Drug: XRD-0394, Radiation: Radiation TherapyPatients with recurrent high-grade glioma (HGG) will be enrolled in Cohort C. Participants enrolled at Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy. Participants enrolled at Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Participants enrolled at Dose-Level 2 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to provide written informed consent.
- ≥18 years of age.
- For Cohorts A and B, radiographic diagnosis of high-grade glioma that is then confirmed with biopsy. Patients with established histologic diagnosis of high-grade glioma is able to enroll on the study without repeating biopsy.
- For Cohort C, histologic diagnosis of high-grade glioma is required to enroll on the study.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Key exclusion criteria (10 listed)
- Prior radiotherapy to the same region or prior anti-glioma systemic therapy in patients with newly diagnosed HGG (Cohorts A and B, not applicable for Cohort C)
- Subjects with bone marrow impairment as evidenced by hemoglobin <8.0 g/dL, neutrophil count <1.5 × 109/L, or platelets <100 × 109/L.
- History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption of XRD-0394, use of percutaneous endoscopic gastrostomy (PEG) tubes.
- Significant cardiac conduction abnormalities, including a history of long corrected QT (QTc) interval syndrome (>450 msec per Fridericia's formula) and/or pacemaker, or impaired cardiovascular function such as New York Heart Association classification >2 at screening.
- Participation in another investigational study of an unapproved drug or device or treatment with another ATM, deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK), or ataxia-telangiectasia and Rad3-related (ATR) inhibitor within 28 days of the first dose of XRD-0394.
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 |
|---|---|---|
| XRD-0394Administered orally; small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and DNA-PK. | Drug | Cohort A: Post-Surgery Dose Escalation, Cohort B: Post-Surgery Dose Escalation, Cohort C: Dose-Escalation (No Surgery), Pre-Surgery Dose-Escalation |
| Radiation TherapyFor Cohort A and Cohort B, the neoadjuvant "boost" radiation dose is 1400cGy delivered over 7 fractions, and the adjuvant radiation dose is 5000cGy delivered over 25 fractions for a total dose of 6400cGy over 32 fractions, accounting for the treatment break between boost and adjuvant RT. For Cohort C, the radiation dose is 3500cGy delivered over 10 fractions. | Radiation | Cohort A: Post-Surgery Dose Escalation, Cohort B: Post-Surgery Dose Escalation, Cohort C: Dose-Escalation (No Surgery), Pre-Surgery Dose-Escalation |
| Surgical ResectionResection of tumor tissue. | Procedure or surgery | Cohort A: Post-Surgery Dose Escalation, Cohort B: Post-Surgery Dose Escalation, Pre-Surgery Dose-Escalation |
Primary outcome
Number of Participants who Experience Dose-Limiting Toxicities (DLTs)
Time frame: End of DLT Monitoring Period (Pre-surgical dose-escalation: Day 8; Cohort C: Day 44; Cohorts A & B: Day 108)
Assessed among patients who receive at least one dose of the study drug and are evaluated for dose-limiting toxicities (DLTs).
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to Year 3 Post-Enrollment
Overall Survival (OS)
Time frame: Up to Year 3 Post-Enrollment
Maximum Concentration (Cmax) of XRD-0394 in Resected Tumor Tissue
Time frame: Day 8 (Day of Surgery)
Area Under the Curve (AUC) of XRD-0394 in Resected Tumor Tissue
Time frame: Day 8 (Day of Surgery)
Time to Maximum Concentration (Tmax) of XRD-0394 in Resected Tumor Tissue
Time frame: Day 8 (Day of Surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jonathan.Yang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Related trials for High-Grade Glioma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
RecruitingEarly Phase 1
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 1
Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas
Currently Only Enrolling Glioblastoma Patients at First Recurrence
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.
Cancer Trials NYU Langone contact
Jonathan Yang, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing XRD-0394, Radiation Therapy and Surgical Resection in people with High-Grade Glioma, run by NYU Langone Health 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Yang, MD, PhD (212-731-6276, Jonathan.Yang@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience Dose-Limiting Toxicities (DLTs) (time frame: End of DLT Monitoring Period (Pre-surgical dose-escalation: Day 8; Cohort C: Day 44; Cohorts A & B: Day 108)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.