Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study

NCT07150416 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: rAdp53-LN001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Pulmonary Ground-Glass Nodules; Lung Neoplasms; Precancerous Conditions

Keywords

p53 gene therapy; nebulized inhalation; Gendicine; Single-Arm Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after the first dose of intervention

Secondary Outcomes (1)

• Incidence of Treatment-Related Adverse Events

  From first dose of study intervention until 30 days after the last dose

Study Arms (1)

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.

Drug: Recombinant Human Ad-p53 Injection

Interventions

Recombinant Human Ad-p53 Injection DRUG

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.

Gendicine Nebulization Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• Shenzhen SiBiono GeneTech Co.,Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (10)

• 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.

  PMID: 35040882 BACKGROUND

• Aoki 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.

  PMID: 22653188 BACKGROUND

• Cheng 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.

  PMID: 38637495 BACKGROUND

• Pan 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.

  PMID: 19103729 BACKGROUND

• Kastan 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.

  PMID: 7606818 BACKGROUND

• Khoo 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.

  PMID: 24577402 BACKGROUND

• Hassin 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.

  PMID: 36216888 BACKGROUND

• Kruiswijk 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.

  PMID: 26122615 BACKGROUND

• Kim 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.

  PMID: 29099488 BACKGROUND

• Mantovani 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.

  PMID: 30538286 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Precancerous Conditions

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jianxing He, Ph.D

CONTACT

86+020-83062807; drjianxing.he@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. No masking (blinding) was used as all participants receive the same active intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Thoracic Surgery

Model Details: This is a single-arm, open-label phase II trial. All enrolled participants will receive the same intervention (nebulized Gendicine®)

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting documents will become available after the publication of the primary findings manuscript (anticipated in \[年份, e.g., 2026\]). Data will be accessible for a minimum of 5 years with no specified end date.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Requestors must sign a data access agreement. Proposals should be directed to the corresponding author or the data access committee at gyfyky\ ec@163.com for approval.

Locations

CN (1)