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Clinical Trials in the USA / NCT04183166
Active, not recruiting Phase 1/2

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

NCT04183166 · tracked via the Priya Life Science USA tracker
Sponsor
Transgene
Phase
Phase 1/2
Started
2019-12-12
Last updated
2026-01-16

Condition(s) studied

Squamous Cell Carcinoma of Head and Neck

Investigational drug(s) / intervention(s)

TG4050

TG4050: Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks

Study summary

This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Signed written informed consent 2. Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx 3. Female or male patients, aged at least 18 years 4. Patients in Complete Response after treatment of their primary tumor. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 6. Adequate hematological, hepatic and renal functions Exclusion Criteria: 1. Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies. 2. Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies. 3. Other active malignancy requiring concurrent systemic intervention. 4. Patients with previous malignancies other than the target malignancy to be investigated in this trial 5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS) 6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection 7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 10 mIU/mL) 8. Treatment with another investigational agent since the beginning of the screening period 9. Uncontrolled intercurrent illness

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Mayo Clinic Jacksonville Jacksonville Florida
Hôpital Saint André - CHU de Bordeaux Bordeaux France
Hôpital de la Timone Marseille France
Institut Curie Paris France
IUCT Toulouse Toulouse France
Institut Gustave Roussy Villejuif France
Hospital Universitari Vall d Hebrón Barcelona Spain
Institut Català d Oncologia - Hospital Duran i Reynals Barcelona Spain
Hospital Clínico San Carlos Madrid Spain
Hospital Universitario La Paz Madrid Spain
Hospital Regional Universitario de Málaga - Hospital Civil Málaga Spain
Complejo Hospitalario Universitario de Santiago Santiago de Compostela Spain
NHS Clatterbridge Cancer Center Liverpool United Kingdom
Aintree University Hospital NHS Fondation Trust Liverpool United Kingdom

More Transgene trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04183166 on ClinicalTrials.gov ↗ ← All trials in the USA