NCT06031636

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jul 2023Jul 2026

Study Start

First participant enrolled

July 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

September 2, 2023

Last Update Submit

September 2, 2023

Conditions

Malignant Pleural Mesothelioma, Advanced

Keywords

Malignant Pleural Mesothelioma, AdvancedOncolytic AdenovirusProgrammed Death Receptor

Outcome Measures

Primary Outcomes (2)

  • ORR(Objective Response Rate)

    The proportion of CR(complete response) and PR(partial response) in all patients.

    36 months

  • DCR(Disease Control Rate)

    The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.

    36 months

Secondary Outcomes (3)

  • PFS(Progression Free Survival)

    36 months

  • OS(Overall Survival)

    36 months

  • AEs(Adverse Events)

    36 months

Study Arms (1)

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 H101Drug: Programmed death receptor-1 inhibitor

Interventions

Oncolytic Adenovirus H101DRUG

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

Also known as: Recombinant Human Type-5 Adenovirus
Oncolytic adenovirus(H101) combined with PD-1 inhibitors
Programmed death receptor-1 inhibitorDRUG

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

Oncolytic adenovirus(H101) combined with PD-1 inhibitors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with malignantpleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.

You may qualify if:

  • Age 18-75 years old (including boundary values), regardless of gender.
  • Confirmed as late stage MPM patients who have failed immunotherapy.
  • The patient or their legal representative can understand and sign the informed consent form.
  • 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.
  • ECOG score 0-2.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Haitao Wang, Ph.D

CONTACT

+86-022-88326385peterrock2000@126.com

Jinhuan Wang, Ph.D

CONTACT

+86-022-88326610wjhhappy2008@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 11, 2023

Study Start

July 20, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

CN(1)