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Trial Title:
A Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer (Delivir)
NCT ID:
NCT05788926
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TG6050
Description:
Oncolytic Vaccinia virus containing genes encoding the human interleukin 12 (IL-12) and
an anti-CTLA4 antibody administered at different dose.
Arm group label:
Dose escalation of TG6050
Summary:
This is a phase I, open-label, dose-escalation trial of TG6050 administered by single or
repeated IV infusion(s).
Detailed description:
This clinical trial aims at determining the dose and schedule of administration of TG6050
for further development, primarly based on the assessment of the safety and tolerability
of single and repeated IV infusions at escalating doses in patients with advanced NSCLC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed written informed consent in accordance with International Conference on
Harmonization-Good Clinical Practice and national/local regulations
2. Male or female patient aged 18 to 75 years
3. Histologically confirmed metastatic (stage IV) NSCLC
4. No known oncogenic driver alteration with available targeted therapy, including
EGFR, HER2, KRASG12C, MET or BRAFV600E gene mutations and ALK, ROS1, or RET gene
fusion/rearrangements. Patients with KRASG12C mutation having received a targeted
therapy will be eligible
5. Have received all standard therapeutic options available, including at least 4
months of treatment with an anti-PD1 or PD-L1 monoclonal antibody and doublet
platinum-containing chemotherapy
6. Have documented progression not earlier than 4 months after initiation of the
anti-PD(L)1 therapy
7. Have at least one measurable lesion according to RECIST 1.1 and at least one lesion
amenable to biopsy
8. Expected life expectancy of at least 3 months
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
10. Time from prior immunotherapy or antibody-based therapy to first TG6050
administration of at least 4 weeks, from prior chemotherapy of at least 3 weeks, and
from palliative radiotherapy of at least 2 weeks
11. Adequate hematological, hepatic, and renal functions
12. Clearance for trial participation after cardiology consultation and cardiologic
investigations
13. Negative pregnancy test in women of childbearing potential (WOCBP)
14. Commitment to use a highly effective contraception method (i.e., with a failure rate
of ≤1 % per year) combined with a barrier method (e.g., condom) during TG6050
administration period and at least 3 months after TG6050 administration, in men and
WOCBP
Exclusion Criteria:
1. Major surgery within 4 weeks of first TG6050 administration
2. Prior treatment with ipilimumab
3. Prior treatment with an oncolytic virus
4. Prior treatment with another investigational agent within 4 weeks of first TG6050
administration
5. Immunodeficiency due to underlying illness and/or immune-suppressive medication
6. Uncontrolled intercurrent illness
7. Active auto-immune disease except hypothyroidism or type I diabetes only requiring
hormone replacement therapy
8. Brain metastases, unless treated and stable for at least 4 weeks after medical
imaging assessment
9. Other malignancies than NSCLC except cutaneous basal cell carcinoma and in situ
carcinoma of the uterine cervix, unless complete remission for at least 5 years
prior to trial entry and no therapy required during the trial
10. Ongoing antiviral therapy active on vaccinia virus (VV), e.g., ribavirin,
interferon/pegylated interferon
11. History of monkeypox infection or anti-monkeypox vaccination
12. History of severe exfoliative skin conditions
13. History of grade ≥ 3 auto-immune manifestations related to ICI therapy
14. History of severe systemic reaction or side-effect after a smallpox vaccination
15. History of solid organ or allogeneic stem cell transplantation
16. Known hypersensitivity to eggs or any TG6050 excipients
17. Positive test for hepatitis C virus (HCV) or hepatitis B virus (HBV) indicating
acute or chronic infection
18. Live virus vaccination within 28 days of TG6050 administration
19. COVID-19 vaccination or infection within 14 days of TG6050 administration
20. Breastfeeding woman
21. Any medical, familial, sociological, or psychiatric condition that in the opinion of
the investigator would prohibit inclusion in the trial
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Investigator:
Last name:
Pr Italiano
Email:
Principal Investigator
Facility:
Name:
Hôpital Timone
Address:
City:
Marseille
Zip:
13000
Country:
France
Status:
Recruiting
Investigator:
Last name:
Pr Greillier
Email:
Principal Investigator
Facility:
Name:
Hôpital Européen Georges Pompidou
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Pr Medioni
Email:
Principal Investigator
Facility:
Name:
CHU Rennes - Hôpital Pontchaillou
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Investigator:
Last name:
Pr Lena
Email:
Principal Investigator
Facility:
Name:
Institut de Cancérologie de l'Ouest
Address:
City:
Saint-Herblain
Zip:
44800
Country:
France
Status:
Recruiting
Investigator:
Last name:
Pr Raimbourg
Email:
Principal Investigator
Start date:
April 5, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Transgene
Agency class:
Industry
Source:
Transgene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05788926
