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Non-small Cell Lung CancerPhase 1NCT05788926

A Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer (Delivir)

A Phase 1 study testing TG6050 in people with Non-small Cell Lung Cancer, run by Transgene at 5 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase I, open-label, dose-escalation trial of TG6050 administered by single or repeated IV infusion(s). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
TG6050
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
5 sitesFrance
Study dates
5 Apr 2023to 23 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent in accordance with International Conference on Harmonization-Good Clinical Practice and national/local regulations
  • Male or female patient aged 18 to 75 years
  • Histologically confirmed metastatic (stage IV) NSCLC
  • 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
  • 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
  • Have documented progression not earlier than 4 months after initiation of the anti-PD(L)1 therapy
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  • Have at least one measurable lesion according to RECIST 1.1 and at least one lesion amenable to biopsy
  • Expected life expectancy of at least 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 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
  • Adequate hematological, hepatic, and renal functions
  • Clearance for trial participation after cardiology consultation and cardiologic investigations
  • Negative pregnancy test in women of childbearing potential (WOCBP)
  • 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

Who cannot join

  • Major surgery within 4 weeks of first TG6050 administration
  • Prior treatment with ipilimumab
  • Prior treatment with an oncolytic virus
  • Prior treatment with another investigational agent within 4 weeks of first TG6050 administration
  • Immunodeficiency due to underlying illness and/or immune-suppressive medication
  • Uncontrolled intercurrent illness
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  • Active auto-immune disease except hypothyroidism or type I diabetes only requiring hormone replacement therapy
  • Brain metastases, unless treated and stable for at least 4 weeks after medical imaging assessment
  • 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
  • Ongoing antiviral therapy active on vaccinia virus (VV), e.g., ribavirin, interferon/pegylated interferon
  • History of monkeypox infection or anti-monkeypox vaccination
  • History of severe exfoliative skin conditions
  • History of grade ≥ 3 auto-immune manifestations related to ICI therapy
  • History of severe systemic reaction or side-effect after a smallpox vaccination
  • History of solid organ or allogeneic stem cell transplantation
  • Known hypersensitivity to eggs or any TG6050 excipients
  • Positive test for hepatitis C virus (HCV) or hepatitis B virus (HBV) indicating acute or chronic infection
  • Live virus vaccination within 28 days of TG6050 administration
  • COVID-19 vaccination or infection within 14 days of TG6050 administration
  • Breastfeeding woman
  • Any medical, familial, sociological, or psychiatric condition that in the opinion of the investigator would prohibit inclusion in the trial

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Institut Bergonié

    Bordeaux, 33000

  • Hôpital Timone

    Marseille, 13000

  • Hôpital Européen Georges Pompidou

    Paris

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35000

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44800

Other trials in France

About this study

Official title: A Phase I Dose-escalation Trial of TG6050 Administered by Intravenous Infusion in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

This is a phase I, open-label, dose-escalation trial of TG6050 administered by single or repeated IV infusion(s).

Read the 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.

Being tested
TG6050
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TG6050Drug

    Oncolytic Vaccinia virus containing genes encoding the human interleukin 12 (IL-12) and an anti-CTLA4 antibody administered at different dose.

Study groups in NCT05788926
Study groupRoleWhat they receive
Dose escalation of TG6050ExperimentalDose escalation with single or repeated administrations of TG6050 by intravenous route in patients with advanced NSCLC.
Receives: Drug: TG6050

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)

    Incidence of Adverse Event reported per NCI-CTCAE v5.0, Dose limiting toxicity, Maximal tolerated dose, Maximum feasible dose and Serious Adverse Events.

    Measured: Up to 5 years

Secondary outcomes (7)

  1. Overall response rate (ORR)

    Proportion of patients whose best response during their participation in the trial is either complete response (CR) or partial response (PR)

    Measured: Up to 1 year

  2. 4-month disease control rate

    Proportion of patients whose tumor assessment at 4 months is either complete response (CR), partial response (PR), or stable disease (SD)

    Measured: Up to 4 months

  3. Overall disease control rate (DCR)

    Proportion of patients whose tumor assessment is either complete response (CR), partial response (PR), or stable disease (SD) during their trial participation

    Measured: Up to 1 year

  4. Progression-free survival (PFS)

    Time from the first TG6050 infusion to documented tumor progression or death due to any cause.

    Measured: Up to 1 year

  5. Overall survival (OS)

    Time from the first TG6050 infusion to death due to any cause.

    Measured: Up to 1 year

  6. Duration of overall response (DoR)

    Time from the first documented response (complete response (CR) or partial response (PR)) to documented tumor progression or death due to underlying cancer.

    Measured: Up to 1 year

  7. Molecular responses (MR)

    Circulating tumor DNA (ctDNA) levels and changes over time

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2023
  2. Study start5 Apr 2023
  3. Primary completion23 Jun 2025
  4. Study completion23 Jun 2025

Why it stopped: Sponsor decision not related to safety

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05788926
Sponsor's protocol ID
TG6050.01
Status last verified
Jul 2025
First submitted
15 Mar 2023
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Azar F, Deforges J, Demeusoit C, Kleinpeter P, Remy C, Silvestre N, Foloppe J, Fend L, Spring-Giusti C, Quemeneur E, Marchand JB. TG6050, an oncolytic vaccinia virus encoding interleukin-12 and anti-CTLA-4 antibody, favors tumor regression via profound immune remodeling of the tumor microenvironment. J Immunother Cancer. 2024 Jul 25;12(7):e009302. doi: 10.1136/jitc-2024-009302.

    PubMed 39060022

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TG6050 in people with Non-small Cell Lung Cancer, run by Transgene at 5 sites in France.

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 14 inclusion and 21 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: stopped early, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision not related to safety). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0) (time frame: Up to 5 years). 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 NCT05788926, which also lists 1 linked publication.

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 9 Jul 2025.

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