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

TERMINATEDPHASE1

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

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

NCT05788926•Transgene

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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 more criteria

Locations (5)

Institut Bergonié

Bordeaux, France

Hôpital Timone

Marseille, France

Hôpital Européen Georges Pompidou

Paris, France

CHU Rennes - Hôpital Pontchaillou

Rennes, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Key Dates

Start Date

April 5, 2023

Primary Completion Date

June 23, 2025

Completion Date

June 23, 2025

Last Updated

July 9, 2025

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

TG6050

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)