Multiple Pulmonary Ground-Glass NodulesPhase 2NCT07150416
Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study
A Phase 2 study testing Recombinant Human Ad-p53 Injection in people with Multiple Pulmonary Ground-Glass Nodules and Lung Neoplasms, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of nebulized inhalation of Recombinant Human Ad-p53 Injection (Gendicine®) for the treatment of multiple ground-glass lung nodules. This is a single-arm, open-label clinical study conducted at The First Affiliated Hospital of Guangzhou Medical University in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Pulmonary Ground-Glass Nodules, Lung Neoplasms, Precancerous Conditions
- What is being tested?
- Recombinant Human Ad-p53 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Feb 2027
- Phase
- Phase 2
- 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
- Age ≥ 18 years.
- CT scan confirms the presence of multiple ground-glass nodules (GGNs), with at least one nodule measuring between 0.5 cm and 3.0 cm in diameter.
- At least one GGN is confirmed as malignant or precancerous (e.g., atypical adenomatous hyperplasia, adenocarcinoma in situ) by histopathology or cytology.
- Life expectancy ≥ 12 weeks.
- Adequate pulmonary function tests (FEV1 ≥ 70% of predicted value).
- Signed informed consent.
Who cannot join
- Pregnant or lactating women.
- History of other active malignancies within the past 5 years.
- Severe cardiac, hepatic, or renal dysfunction (e.g., NYHA class III/IV heart failure, ALT/AST > 3×ULN, Cr > 1.5×ULN).
- Uncontrolled systemic infection or immunodeficiency diseases.
- Participation in another interventional clinical trial within 4 weeks prior to enrollment.
- Known hypersensitivity to any component of the recombinant human p53 adenovirus injection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Hengrui Liang, M.D., +86 15625064712, hengrui_liang@163.com
About this study
Official title: A Single-Arm Clinical Study of Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection (Gendicine) for Treatment of Multiple Ground-Glass Lung Nodules
This study aims to evaluate the safety and efficacy of nebulized inhalation of Recombinant Human Ad-p53 Injection (Gendicine®) for the treatment of multiple ground-glass lung nodules. This is a single-arm, open-label clinical study conducted at The First Affiliated Hospital of Guangzhou Medical University in China. We plan to enroll approximately 38 patients who have been diagnosed with multiple ground-glass nodules. All participants in this study will receive the nebulized Gendicine® treatment. After the treatment, we will monitor changes in the nodules through regular chest CT scans and record any potential treatment-related reactions to determine if this novel therapy is safe and effective. This study has been approved by the hospital's Ethics Committee.
Read the detailed description
Background: Ground-glass nodules (GGN) are a common manifestation of early-stage lung adenocarcinoma, and their management strategy (active surveillance or surgical intervention) often presents a dilemma for clinicians and patients. Gendicine® (Recombinant Human Ad-p53 Injection) is a gene therapy product approved in China. Previous studies have shown its ability to induce tumor cell apoptosis and enhance the sensitivity to radiotherapy and chemotherapy in various solid tumors. This study aims to investigate this innovative approach of local administration via nebulized inhalation for treating precancerous lesions or early-stage lung cancer.
Methods: This is a single-arm, open-label, phase II clinical trial utilizing the Simon's optimal two-stage design. The first stage plans to enroll 16 patients. If ≥1 objective response (according to RECIST 1.1 criteria) is observed, the study will proceed to the second stage, with a total planned enrollment of 30 evaluable patients (38 subjects will be recruited accounting for a 20% dropout rate). Participants are patients with multiple ground-glass nodules confirmed by imaging, with at least one nodule pathologically confirmed as malignant. The intervention is nebulized inhalation of Gendicine® at a dose of 1×10¹² VP per time, administered once every three days, for a total of four times. The primary endpoint is the Objective Response Rate (ORR), defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) at 6 months post-treatment. Secondary endpoints include safety (assessing adverse events according to CTCAE v5.0), changes in tumor markers, and quality of life scores.
Significance: This study is the world's first clinical trial to explore nebulized inhalation of a gene therapy product for the treatment of lung nodules. Positive results would provide a novel, non-invasive treatment strategy for the very early intervention of lung cancer, potentially delaying or preventing nodule malignancy and avoiding surgical trauma.
- Being tested
- Recombinant Human Ad-p53 Injection
- Keywords
- p53 gene therapy, nebulized inhalation, Gendicine, Single-Arm Trial
- Medical subject headings
- Lung Neoplasms, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Ad-p53 InjectionDrug
A replication-deficient recombinant human type 5 adenovirus vector encoding the human wild-type p53 tumor suppressor gene. For this study, it will be administered via nebulized inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Gendicine Nebulization Arm | Experimental | Participants in this single arm of the study will all receive the active intervention, which is Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection (Gendicine®), at a dose of 1×10¹² VP per session. The treatment will be administered once every three days, for a total of four sessions. Receives: Drug: Recombinant Human Ad-p53 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, based on chest CT scan assessments. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Measured: 6 months after the first dose of intervention
Secondary outcomes (1)
Incidence of Treatment-Related Adverse Events
The number and percentage of participants experiencing any treatment-related adverse event (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: From first dose of study intervention until 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple Pulmonary Ground-Glass NodulesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label phase II trial. All enrolled participants will receive the same intervention (nebulized Gendicine®)
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen SiBiono GeneTech Co.,Ltd
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150416
- Sponsor's protocol ID
- rAdp53-LN001
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this article will be shared. This includes data on radiological response (CT imaging), safety (adverse events), and baseline characteristics. The data will become available following the publication of the primary results manuscript, with no specified end date. Data will be accessible through a public data repository such as Figshare or ClinicalTrials.gov. Requestors will be required to sign a data access agreement and provide a methodologically sound research proposal for approval by the study steering committee.
Publications
Mazzone PJ, Lam L. Evaluating the Patient With a Pulmonary Nodule: A Review. JAMA. 2022 Jan 18;327(3):264-273. doi: 10.1001/jama.2021.24287.
PubMed 35040882Aoki T, Hanamiya M, Uramoto H, Hisaoka M, Yamashita Y, Korogi Y. Adenocarcinomas with predominant ground-glass opacity: correlation of morphology and molecular biomarkers. Radiology. 2012 Aug;264(2):590-6. doi: 10.1148/radiol.12111337. Epub 2012 May 31.
PubMed 22653188Cheng B, Li C, Li J, Gong L, Liang P, Chen Y, Zhan S, Xiong S, Zhong R, Liang H, Feng Y, Wang R, Wang H, Zheng H, Liu J, Zhou C, Shao W, Qiu Y, Sun J, Xie Z, Liang Z, Yang C, Cai X, Su C, Wang W, He J, Liang W. The activity and immune dynamics of PD-1 inhibition on high-risk pulmonary ground glass opacity lesions: insights from a single-arm, phase II trial. Signal Transduct Target Ther. 2024 Apr 19;9(1):93. doi: 10.1038/s41392-024-01799-z.
PubMed 38637495Pan JJ, Zhang SW, Chen CB, Xiao SW, Sun Y, Liu CQ, Su X, Li DM, Xu G, Xu B, Lu YY. Effect of recombinant adenovirus-p53 combined with radiotherapy on long-term prognosis of advanced nasopharyngeal carcinoma. J Clin Oncol. 2009 Feb 10;27(5):799-804. doi: 10.1200/JCO.2008.18.9670. Epub 2008 Dec 22.
PubMed 19103729Kastan MB, Canman CE, Leonard CJ. P53, cell cycle control and apoptosis: implications for cancer. Cancer Metastasis Rev. 1995 Mar;14(1):3-15. doi: 10.1007/BF00690207.
PubMed 7606818Khoo KH, Verma CS, Lane DP. Drugging the p53 pathway: understanding the route to clinical efficacy. Nat Rev Drug Discov. 2014 Mar;13(3):217-36. doi: 10.1038/nrd4236.
PubMed 24577402Hassin O, Oren M. Drugging p53 in cancer: one protein, many targets. Nat Rev Drug Discov. 2023 Feb;22(2):127-144. doi: 10.1038/s41573-022-00571-8. Epub 2022 Oct 10.
PubMed 36216888Kruiswijk F, Labuschagne CF, Vousden KH. p53 in survival, death and metabolic health: a lifeguard with a licence to kill. Nat Rev Mol Cell Biol. 2015 Jul;16(7):393-405. doi: 10.1038/nrm4007.
PubMed 26122615Kim MP, Lozano G. Mutant p53 partners in crime. Cell Death Differ. 2018 Jan;25(1):161-168. doi: 10.1038/cdd.2017.185. Epub 2017 Nov 3.
PubMed 29099488Mantovani F, Collavin L, Del Sal G. Mutant p53 as a guardian of the cancer cell. Cell Death Differ. 2019 Jan;26(2):199-212. doi: 10.1038/s41418-018-0246-9. Epub 2018 Dec 11.
PubMed 30538286
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Clinical Study of Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection (Gendicine) for Treatment of Multiple Ground-Glass Lung Nodules
- ClinicalTrials.gov ID
- NCT07150416
- Acronym / sponsor ID
- rAdp53-LN001
- Keywords
- p53 gene therapy, nebulized inhalation, Gendicine, Single-Arm Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shenzhen SiBiono GeneTech Co.,Ltd
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 2 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 study aims to evaluate the safety and efficacy of nebulized inhalation of Recombinant Human Ad-p53 Injection (Gendicine®) for the treatment of multiple ground-glass lung nodules. This is a single-arm, open-label clinical study conducted at The First Affiliated Hospital of Guangzhou Medical University in China. We plan to enroll approximately 38 patients who have been diagnosed with multiple ground-glass nodules. All participants in this study will receive the nebulized Gendicine® treatment. After the treatment, we will monitor changes in the nodules through regular chest CT scans and record any potential treatment-related reactions to determine if this novel therapy is safe and effective. This study has been approved by the hospital's Ethics Committee.
Detailed description
Background: Ground-glass nodules (GGN) are a common manifestation of early-stage lung adenocarcinoma, and their management strategy (active surveillance or surgical intervention) often presents a dilemma for clinicians and patients. Gendicine® (Recombinant Human Ad-p53 Injection) is a gene therapy product approved in China. Previous studies have shown its ability to induce tumor cell apoptosis and enhance the sensitivity to radiotherapy and chemotherapy in various solid tumors. This study aims to investigate this innovative approach of local administration via nebulized inhalation for treating precancerous lesions or early-stage lung cancer.
Methods: This is a single-arm, open-label, phase II clinical trial utilizing the Simon's optimal two-stage design. The first stage plans to enroll 16 patients. If ≥1 objective response (according to RECIST 1.1 criteria) is observed, the study will proceed to the second stage, with a total planned enrollment of 30 evaluable patients (38 subjects will be recruited accounting for a 20% dropout rate). Participants are patients with multiple ground-glass nodules confirmed by imaging, with at least one nodule pathologically confirmed as malignant. The intervention is nebulized inhalation of Gendicine® at a dose of 1×10¹² VP per time, administered once every three days, for a total of four times. The primary endpoint is the Objective Response Rate (ORR), defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) at 6 months post-treatment. Secondary endpoints include safety (assessing adverse events according to CTCAE v5.0), changes in tumor markers, and quality of life scores.
Significance: This study is the world's first clinical trial to explore nebulized inhalation of a gene therapy product for the treatment of lung nodules. Positive results would provide a novel, non-invasive treatment strategy for the very early intervention of lung cancer, potentially delaying or preventing nodule malignancy and avoiding surgical trauma.
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 single-arm, open-label phase II trial. All enrolled participants will receive the same intervention (nebulized Gendicine®)
| Arm | Type | Receives |
|---|---|---|
| Gendicine Nebulization Arm | Experimental | Drug: Recombinant Human Ad-p53 InjectionParticipants in this single arm of the study will all receive the active intervention, which is Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection (Gendicine®), at a dose of 1×10¹² VP per session. The treatment will be administered once every three days, for a total of four sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- CT scan confirms the presence of multiple ground-glass nodules (GGNs), with at least one nodule measuring between 0.5 cm and 3.0 cm in diameter.
- At least one GGN is confirmed as malignant or precancerous (e.g., atypical adenomatous hyperplasia, adenocarcinoma in situ) by histopathology or cytology.
- Life expectancy ≥ 12 weeks.
- Adequate pulmonary function tests (FEV1 ≥ 70% of predicted value).
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- History of other active malignancies within the past 5 years.
- Severe cardiac, hepatic, or renal dysfunction (e.g., NYHA class III/IV heart failure, ALT/AST > 3×ULN, Cr > 1.5×ULN).
- Uncontrolled systemic infection or immunodeficiency diseases.
- Participation in another interventional clinical trial within 4 weeks prior to enrollment.
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 |
|---|---|---|
| Recombinant Human Ad-p53 InjectionA replication-deficient recombinant human type 5 adenovirus vector encoding the human wild-type p53 tumor suppressor gene. For this study, it will be administered via nebulized inhalation. | Drug | Gendicine Nebulization Arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: 6 months after the first dose of intervention
The proportion of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria, based on chest CT scan assessments. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
1 secondary outcome
Incidence of Treatment-Related Adverse Events
Time frame: From first dose of study intervention until 30 days after the last dose
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 Sep 2025.
- Background: PubMed 35040882Mazzone PJ, Lam L. Evaluating the Patient With a Pulmonary Nodule: A Review. JAMA. 2022 Jan 18;327(3):264-273. doi: 10.1001/jama.2021.24287.
- Background: PubMed 22653188Aoki T, Hanamiya M, Uramoto H, Hisaoka M, Yamashita Y, Korogi Y. Adenocarcinomas with predominant ground-glass opacity: correlation of morphology and molecular biomarkers. Radiology. 2012 Aug;264(2):590-6. doi: 10.1148/radiol.12111337. Epub 2012 May 31.
- Background: PubMed 38637495Cheng B, Li C, Li J, Gong L, Liang P, Chen Y, Zhan S, Xiong S, Zhong R, Liang H, Feng Y, Wang R, Wang H, Zheng H, Liu J, Zhou C, Shao W, Qiu Y, Sun J, Xie Z, Liang Z, Yang C, Cai X, Su C, Wang W, He J, Liang W. The activity and immune dynamics of PD-1 inhibition on high-risk pulmonary ground glass opacity lesions: insights from a single-arm, phase II trial. Signal Transduct Target Ther. 2024 Apr 19;9(1):93. doi: 10.1038/s41392-024-01799-z.
- Background: PubMed 19103729Pan JJ, Zhang SW, Chen CB, Xiao SW, Sun Y, Liu CQ, Su X, Li DM, Xu G, Xu B, Lu YY. Effect of recombinant adenovirus-p53 combined with radiotherapy on long-term prognosis of advanced nasopharyngeal carcinoma. J Clin Oncol. 2009 Feb 10;27(5):799-804. doi: 10.1200/JCO.2008.18.9670. Epub 2008 Dec 22.
- Background: PubMed 7606818Kastan MB, Canman CE, Leonard CJ. P53, cell cycle control and apoptosis: implications for cancer. Cancer Metastasis Rev. 1995 Mar;14(1):3-15. doi: 10.1007/BF00690207.
- Background: PubMed 24577402Khoo KH, Verma CS, Lane DP. Drugging the p53 pathway: understanding the route to clinical efficacy. Nat Rev Drug Discov. 2014 Mar;13(3):217-36. doi: 10.1038/nrd4236.
- Background: PubMed 36216888Hassin O, Oren M. Drugging p53 in cancer: one protein, many targets. Nat Rev Drug Discov. 2023 Feb;22(2):127-144. doi: 10.1038/s41573-022-00571-8. Epub 2022 Oct 10.
- Background: PubMed 26122615Kruiswijk F, Labuschagne CF, Vousden KH. p53 in survival, death and metabolic health: a lifeguard with a licence to kill. Nat Rev Mol Cell Biol. 2015 Jul;16(7):393-405. doi: 10.1038/nrm4007.
- Background: PubMed 29099488Kim MP, Lozano G. Mutant p53 partners in crime. Cell Death Differ. 2018 Jan;25(1):161-168. doi: 10.1038/cdd.2017.185. Epub 2017 Nov 3.
- Background: PubMed 30538286Mantovani F, Collavin L, Del Sal G. Mutant p53 as a guardian of the cancer cell. Cell Death Differ. 2019 Jan;26(2):199-212. doi: 10.1038/s41418-018-0246-9. Epub 2018 Dec 11.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this article will be shared. This includes data on radiological response (CT imaging), safety (adverse events), and baseline characteristics. The data will become available following the publication of the primary results manuscript, with no specified end date. Data will be accessible through a public data repository such as Figshare or ClinicalTrials.gov. Requestors will be required to sign a data access agreement and provide a methodologically sound research proposal for approval by the study steering committee.
Related trials for Multiple Pulmonary Ground-Glass Nodules
Not yet recruitingObservational study
Deep Learning Time-Series Prediction of Long-Term Growth Patterns of Pulmonary Ground-Glass Nodules Using Serial CT
Pulmonary Nodules, Lung Neoplasms
Not yet recruiting
Hybrid Robot-Assisted Percutaneous Ablation and Non-Intubated VATS for Multiple Pulmonary Nodules
Multiple Pulmonary Nodules
Not yet recruiting
Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nodules With Ground-glass Opacity
Pulmonary Nodules, Ground-glass Opacity
Recruiting
SLND or Not in cT1 GGO Invasive Lung Adenocarcinoma (ECTOP-1009)
Carcinoma, Non-Small-Cell Lung
Not yet recruiting
A Clinical Trial of Percutaneous Lung Ablation Using Navigational Positioning Robot-assisted Procedures
Percutaneous Lung Ablation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Ad-p53 Injection in people with Multiple Pulmonary Ground-Glass Nodules and Lung Neoplasms, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Sep 2025. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jianxing He, Ph.D (86+020-83062807, drjianxing.he@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 6 months after the first dose of intervention). 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 NCT07150416, which also lists 10 linked publications.
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 Sep 2025.