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Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT06031636
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Second Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Oncolytic Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.

Condition or disease Intervention/treatment
Malignant Pleural Mesothelioma, Advanced Drug: Oncolytic Adenovirus H101 Drug: Programmed death receptor-1 inhibitor

Detailed Description:
By monitoring the clinical symptoms of patients with advanced immune resistant pleural mesothelioma treated with adenovirus injection combined with programmed death receptor (PD-1) inhibitors, we analyze and explore the effectiveness and safety of using oncolytic virus drugs. Exploring the influencing factors of using oncolytic adenovirus injection combined with PD-1 inhibitors to reverse immune resistance in MPM patients. Evaluate the safety of the drug, and finally evaluate the quality of life of patients using oncolytic adenovirus injection(H101) combined with PD-1 inhibitors.
Study Design
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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observation of the Efficacy and Safety of Oncolytic Adenovirus Injection Combined With Programmed Death Receptor Inhibitors in Treatment of Advanced Malignant Pleural Mesothelioma : a Single Center, Prospective, Case Registration Study
Actual Study Start Date : July 20, 2023
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Oncolytic adenovirus(H101) combined with PD-1 inhibitors
This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.
 Drug: Oncolytic Adenovirus H101
The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles
Other Name: Recombinant Human Type-5 Adenovirus

Drug: Programmed death receptor-1 inhibitor
The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles


Outcome Measures
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Primary Outcome Measures :
  1. ORR(Objective Response Rate) [ Time Frame: 36 months ]
    The proportion of CR(complete response) and PR(partial response) in all patients.

  2. DCR(Disease Control Rate) [ Time Frame: 36 months ]
    The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.


Secondary Outcome Measures :
  1. PFS(Progression Free Survival) [ Time Frame: 36 months ]
    Refers to the time from the first treatment day to the first occurrence of disease progression or death from any cause (whichever occurs first), and the end point event is determined by the investigator according to RECIST version1.1.

  2. OS(Overall Survival) [ Time Frame: 36 months ]
    Time between the date of grouping and death from any cause or the end of the last follow-up visit.

  3. AEs(Adverse Events) [ Time Frame: 36 months ]
    Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of H101 will be recorded.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with malignantpleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.
Criteria

Inclusion Criteria:

  1. Age 18-75 years old (including boundary values), regardless of gender.
  2. Confirmed as late stage MPM patients who have failed immunotherapy.
  3. The patient or their legal representative can understand and sign the informed consent form.
  4. At least one lesion that can safely undergo intratumoral injection or intrapleural injection of oncolytic adenovirus as the target lesion, with a diameter of spiral CT ≥ 1cm or ordinary CT ≥ 2cm, and can be measured through imaging methods.
  5. ECOG score 0-2.

Exclusion Criteria:

  1. Physicians participating in the study believe that patients may not be able to provide continuous follow-up information.
  2. Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases).
  3. Contraindications to relevant drugs (such as oncolytic adenoviruses, PD-1 inhibitors, etc.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031636


Contacts
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Contact: Haitao Wang, Ph.D +86-022-88326385 peterrock2000@126.com
Contact: Jinhuan Wang, Ph.D +86-022-88326610 wjhhappy2008@163.com

Locations
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China, Tianjin
Tianjin Medical Unversity Second Hospital Recruiting
Tianjin, Tianjin, China
Contact: Haitao Wang, Ph.D    +86-022-88326385    peterrock2000@126.com   
Contact: Lili Wang, MM    +86-022-88326610    wangliliaigang@163.com   
Principal Investigator: Haitao Wang         
Sub-Investigator: Lili Wang         
Sub-Investigator: Jinhuan Wang         
Sub-Investigator: Dingkun Hou         
Sub-Investigator: Lei Wang         
Sponsors and Collaborators
Tianjin Medical University Second Hospital
More Information
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Responsible Party: Tianjin Medical University Second Hospital
ClinicalTrials.gov Identifier: NCT06031636    
Other Study ID Numbers: H101 for MPM
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin Medical University Second Hospital:
Malignant Pleural Mesothelioma, Advanced
Oncolytic Adenovirus
Programmed Death Receptor
Additional relevant MeSH terms:
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Adenoviridae Infections
Mesothelioma
Mesothelioma, Malignant
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Lung Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Infections