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

NCT05788926 | Terminated Phase 1 DMC

• 1 other identifier: TG6050.01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (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.

  Up to 5 years

Secondary Outcomes (7)

• Overall response rate (ORR)

  Up to 1 year

• 4-month disease control rate

  Up to 4 months

• Overall disease control rate (DCR)

  Up to 1 year

• Progression-free survival (PFS)

  Up to 1 year

• Overall survival (OS)

  Up to 1 year

Study Arms (1)

Dose escalation of TG6050

EXPERIMENTAL

Dose escalation with single or repeated administrations of TG6050 by intravenous route in patients with advanced NSCLC.

Drug: TG6050

Interventions

TG6050 DRUG

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

Dose escalation of TG6050

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Transgene: lead

Study Sites (5)

Institut Bergonié

Bordeaux, 33000, France

Location

Hôpital Timone

Marseille, 13000, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, 35000, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44800, France

Location

Related Publications (1)

• 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.

  PMID: 39060022 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: April 5, 2023
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

FR (5)