Advanced Malignant Solid NeoplasmPhase 1NCT07189195
TR-002 for the Treatment of Advanced Unresectable Metastatic Solid Tumors Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma
A Phase 1 study testing TR-002 in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by University of California, Davis at 1 site in United States.
Trial summary
This phase I trial tests the safety, side effects and best dose of TR-002 for the treatment of solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable), that has spread from where it first… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- TR-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2025to 7 Feb 2030
- Phase
- 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
- Aged 18 or over at the time of consent
- Pathology or histology-confirmed metastatic or unresectable solid tumor for which standard systemic treatments are no longer effective or not tolerated
- For the expansion cohort, participants must have pathology or histology-confirmed metastatic or unresectable pancreatic adenocarcinoma that is refractory and/or intolerant to all standard-of-care systemic treatments (including gemcitabine, nab-paclitaxel, fluoropyrimidine, oxaliplatin, and irinotecan)
- Participants in dose escalation may have measurable and/or non-measurable disease. Imaging for disease assessment of measurable and non-measurable disease must be completed within 28 days prior to registration. Participants in dose expansion must have measurable disease per Response Evaluation Criteira in Solid Tumors (RECIST) 1.1
- Adequate cardiac function, assessed by multiple-gated acquisition (MUGA) scan or echocardiography (left ventricular ejection fraction of > 50%)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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- Absolute neutrophil count ≥ 1,000/mcL
- Platelets ≥ 75,000/mcL
- Hemoglobin ≥ 8g/dL
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (< 3 x ULN in patients with known Gilberts)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN (< 5 x ULN in patients with known liver metastases)
- Creatinine ≤ 1.5 x institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2
- For people of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method through 3 months following the last dose of study treatment
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Lactating or pregnant patients or patients of reproductive potential not willing to use effective methods of contraception
- Clinically significant toxicities from most recent therapy or intervention prior to study enrollment that have not resolved to baseline or grade 1 (exceptions include alopecia and grade 2 sensory neuropathy)
- Participant with a history of the following significant cardiovascular disease will be excluded:
- Participant has a history of myocardial infarction or unstable angina within 6 months prior to day 1.
- Participant has New York Heart Association (NYHA) Class II or greater congetive heart failure (CHF).
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study treatment.
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- Participant has cardiac arrhythmia, complete left bundle branch block, obligate use of a cardiac pacemaker, long QT syndrome or right bundle branch block with left anterior hemiblock (bifascicular block).
- History of congenital long QT syndrome or prolonged corrected QT interval (QTc) > 470 msec for females and males using Fridericia's formula (unless a pacemaker is in place or additional clinically non-significant condition such as bundle-branch block necessitating use of an alternate formula per cardiologist calculation) or uncorrectable abnormalities in serum electrolytes (i.e., sodium, potassium, calcium, magnesium, phosphorus). An average of triplicate readings for assessing QTc interval may be used
- Active bacterial, fungal, and viral infection, as documented by positive culture, radiological imaging techniques, septic fever, or septic shock symptoms
- Known hypersensitivity to 4-aminoquinolone compounds
- Retinal or visual field changes of any etiology
- History of psoriasis
- History of porphyria
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- History of seizure disorder
- Any other condition that could compromise the subject's safety or put the study outcomes at undue risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Office of Clinical Research, 916-382-6970, OCRReferral@health.ucdavis.edu
Edward J. Kim, MD, PhD
About this study
Official title: A Phase 1 Study of Bisaminoquinoline Derivative (TR-002) for Injection for Advanced Treatment-Refractory Solid Tumors
This phase I trial tests the safety, side effects and best dose of TR-002 for the treatment of solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable), that has spread from where it first started (primary site) to other places in the body (metastatic) and unresectable or metastatic pancreatic adenocarcinoma that does not respond to treatment (refractory). Chemotherapy drugs, such as TR-002, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. TR-002 may be safe and tolerable in treating patients with advanced, unresectable or metastatic solid tumors and unresectable or metastatic, refractory pancreatic adenocarcinoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD), which will also be the recommended phase 2 dose (RP2D) of Nadofaragene Firadenovec (TR-002) for the treatment of advanced treatment-refractory solid tumors.
II. To evaluate the toxicities of TR-002 administered intravenous weekly.
SECONDARY OBJECTIVES:
- To obtain preliminary assessment of anti-tumor activity of TR-002 administered intravenous weekly at the RP2D.
II. To evaluate the pharmacokinetics of TR-002 administered intravenous weekly.
EXPLORATORY OBJECTIVE:
- To assess the effects of TR-002 on pharmacodynamic biomarkers relating to the mechanism of action.
OUTLINE: This is a dose-escalation study of TR-002 followed by a dose-expansion study.
Patients receive TR-002 intravenously (IV), over 1 hour, on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or multigated acquisition (MUGA) scan during screening and undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), tumor biopsy and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days and every 60 days for 1 year.
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Refractory Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Being tested
- TR-002
- Medical subject headings
- Neoplasm Metastasis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-002Drug
Also called Bisaminoquinoline Derivative
Weekly intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment (TR-002) | Experimental | Patients receive TR-002 IV, over 1 hour, on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan during screening and undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. Receives: Drug: TR-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLTs)
The proportion of DLTs at each dose level will be reported with exact binomial 95% confidence intervals.
Measured: From first dose of TR-002 to day 28
Number of participants experiencing treatment-related adverse events
Classified by severity, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: From first dose of TR-002 to 90 days following the last dose
Secondary outcomes (9)
Objective response rate (ORR)
Defined as the proportion of eligible subjects who have a complete response or partial response using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Estimate for ORR will be provided, along with exact 2-sided 95% confidence interval.
Measured: From the first dose of TR-002 up to 1 year post last dose
Progression free survival
Will estimate median survival times together with their 95% confidence intervals with the Kaplan-Meier method, and report number of events.
Measured: From the date of enrollment until the first occurrence of disease progression, or death from any cause, whichever occurs earlier, up to 1 year post last dose
Overall survival
Will estimate median survival times together with their 95% confidence intervals with the Kaplan-Meier method, and report number of events.
Measured: From the date of enrollment until death from any cause, up to 1 year post last dose
Steady state through concentrations in serum
Steady state through concentrations will be calculated using non-compartmental or compartmental PK methods, and will be compared across dose levels using non-parametric statistical testing techniques.
Measured: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) will be calculated using non-compartmental or compartmental PK methods, and will be compared across dose levels using non-parametric statistical testing techniques.
Measured: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Area under the serum concentration
Area under the plasma concentration versus time curve (AUC) will be calculated using non-compartmental or compartmental PK methods, and will be compared across dose levels using non-parametric statistical testing techniques.
Measured: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Half-life
Half-life will be calculated using non-compartmental or compartmental PK methods, and will be compared across dose levels using non-parametric statistical testing techniques.
Measured: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Apparent clearance/bioavailability
Apparent clearance/bioavailability will be calculated using non-compartmental or compartmental PK methods, and will be compared across dose levels using non-parametric statistical testing techniques.
Measured: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Apparent volume of distribution
Apparent volume of distribution will be calculated using non-compartmental or compartmental PK methods, and will be compared across dose levels using non-parametric statistical testing techniques
Measured: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start7 Nov 2025
- Primary completion7 Nov 2029 (estimated)
- Study completion7 Feb 2030 (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 Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward J Kim, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189195
- Sponsor's protocol ID
- UCDCC305
- Other IDs
- NCI-2025-06181, UCDCC305, P30CA093373
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mahri S, Tang M, Zong Q, Kim EJ, Lin TY, Li Y. Towards the clinical translation of a novel autophagy inhibitor: Bisaminoquinoline derivative nanoparticles. Biomaterials. 2026 Dec;335:124361. doi: 10.1016/j.biomaterials.2026.124361. Epub 2026 Jun 2.
PubMed 42247927
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Bisaminoquinoline Derivative (TR-002) for Injection for Advanced Treatment-Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT07189195
- Acronym / sponsor ID
- UCDCC305
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Refractory Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 7 Nov 2029 (estimated)
- Study completion
- 7 Feb 2030 (estimated)
- First posted
- 23 Sep 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 phase I trial tests the safety, side effects and best dose of TR-002 for the treatment of solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable), that has spread from where it first started (primary site) to other places in the body (metastatic) and unresectable or metastatic pancreatic adenocarcinoma that does not respond to treatment (refractory). Chemotherapy drugs, such as TR-002, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. TR-002 may be safe and tolerable in treating patients with advanced, unresectable or metastatic solid tumors and unresectable or metastatic, refractory pancreatic adenocarcinoma.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD), which will also be the recommended phase 2 dose (RP2D) of Nadofaragene Firadenovec (TR-002) for the treatment of advanced treatment-refractory solid tumors.
II. To evaluate the toxicities of TR-002 administered intravenous weekly.
SECONDARY OBJECTIVES:
- To obtain preliminary assessment of anti-tumor activity of TR-002 administered intravenous weekly at the RP2D.
II. To evaluate the pharmacokinetics of TR-002 administered intravenous weekly.
EXPLORATORY OBJECTIVE:
- To assess the effects of TR-002 on pharmacodynamic biomarkers relating to the mechanism of action.
OUTLINE: This is a dose-escalation study of TR-002 followed by a dose-expansion study.
Patients receive TR-002 intravenously (IV), over 1 hour, on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or multigated acquisition (MUGA) scan during screening and undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), tumor biopsy and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days and every 60 days for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (TR-002) | Experimental | Drug: TR-002Patients receive TR-002 IV, over 1 hour, on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan during screening and undergo CT scan, MRI, tumor biopsy and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged 18 or over at the time of consent
- Pathology or histology-confirmed metastatic or unresectable solid tumor for which standard systemic treatments are no longer effective or not tolerated
- For the expansion cohort, participants must have pathology or histology-confirmed metastatic or unresectable pancreatic adenocarcinoma that is refractory and/or intolerant to all standard-of-care systemic treatments (including gemcitabine, nab-paclitaxel, fluoropyrimidine, oxaliplatin, and irinotecan)
- Participants in dose escalation may have measurable and/or non-measurable disease. Imaging for disease assessment of measurable and non-measurable disease must be completed within 28 days prior to registration. Participants in dose expansion must have measurable disease per Response Evaluation Criteira in Solid Tumors (RECIST) 1.1
- Adequate cardiac function, assessed by multiple-gated acquisition (MUGA) scan or echocardiography (left ventricular ejection fraction of > 50%)
Key exclusion criteria (16 listed)
- Lactating or pregnant patients or patients of reproductive potential not willing to use effective methods of contraception
- Clinically significant toxicities from most recent therapy or intervention prior to study enrollment that have not resolved to baseline or grade 1 (exceptions include alopecia and grade 2 sensory neuropathy)
- Participant with a history of the following significant cardiovascular disease will be excluded:
- Active bacterial, fungal, and viral infection, as documented by positive culture, radiological imaging techniques, septic fever, or septic shock symptoms
- Known hypersensitivity to 4-aminoquinolone compounds
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 |
|---|---|---|
| TR-002Also: Bisaminoquinoline DerivativeWeekly intravenous infusion | Drug | Treatment (TR-002) |
Primary outcome
Incidence of dose limiting toxicity (DLTs)
Time frame: From first dose of TR-002 to day 28
The proportion of DLTs at each dose level will be reported with exact binomial 95% confidence intervals.
Number of participants experiencing treatment-related adverse events
Time frame: From first dose of TR-002 to 90 days following the last dose
Classified by severity, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
9 secondary outcomes
Objective response rate (ORR)
Time frame: From the first dose of TR-002 up to 1 year post last dose
Progression free survival
Time frame: From the date of enrollment until the first occurrence of disease progression, or death from any cause, whichever occurs earlier, up to 1 year post last dose
Overall survival
Time frame: From the date of enrollment until death from any cause, up to 1 year post last dose
Steady state through concentrations in serum
Time frame: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Peak Plasma Concentration (Cmax)
Time frame: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Area under the serum concentration
Time frame: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Half-life
Time frame: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Apparent clearance/bioavailability
Time frame: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
Apparent volume of distribution
Time frame: Within 15 minutes prior to Cycle 1 Day 1 infusion, end of Cycle 1 Day 15 infusion, and 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours post-Cycle 1 Day 15 infusion
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 16 Jul 2026.
- Derived from this study: PubMed 42247927Mahri S, Tang M, Zong Q, Kim EJ, Lin TY, Li Y. Towards the clinical translation of a novel autophagy inhibitor: Bisaminoquinoline derivative nanoparticles. Biomaterials. 2026 Dec;335:124361. doi: 10.1016/j.biomaterials.2026.124361. Epub 2026 Jun 2.
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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.
Edward J Kim, MD, PhD principal investigator
University of California, Davis
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 TR-002 in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by University of California, Davis 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 15 inclusion and 16 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 16 Jul 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?
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?
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 Office of Clinical Research (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLTs) (time frame: From first dose of TR-002 to day 28). 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 NCT07189195, 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 16 Jul 2026.