A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

NCT04183166 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TG4050.02
• Study Type: interventional
• Target: 80
• Locations: 4 countries
• Sites: 14

Brief 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).

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (2)

• Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)

  Incidence of Adverse Event reported per CTCAE v5.

  Up to 2 Years.

• Phase I/II: Disease-Free Survival

  Time from randomization to documented recurrence of disease.

  Up to 2 years.

Secondary Outcomes (6)

• Phase I: Disease-Free Survival

  Up to 2 Years.

• Phase I: Tumor response rate

  Up to 2 years.

• Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)

  Up to 2 years.

• Phase I/II: Distant Metastases-Free Survival

  Up to 2 years.

• Phase I/II: Loco-Regional Relapse-Free Survival

  Up to 2 years.

Study Arms (2)

Arm A : Early study treatment initiation

EXPERIMENTAL

TG4050 treatment initiation at completion of primary treatment

Drug: TG4050

Arm B: Study treatment initiation at recurrence

EXPERIMENTAL

TG4050 treatment initiation at the time of recurrence

Drug: TG4050

Interventions

TG4050 DRUG

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

Arm A : Early study treatment initiation; Arm B: Study treatment initiation at recurrence

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent
• Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
• Female or male patients, aged at least 18 years
• Patients in Complete Response after treatment of their primary tumor.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Adequate hematological, hepatic and renal functions

You may not qualify if:

• 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.
• 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.
• Other active malignancy requiring concurrent systemic intervention.
• Patients with previous malignancies other than the target malignancy to be investigated in this trial
• Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
• Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
• 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)
• Treatment with another investigational agent since the beginning of the screening period
• Uncontrolled intercurrent illness

Sponsors & Collaborators

• Transgene: lead

Study Sites (14)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Hôpital Saint André - CHU de Bordeaux

Bordeaux, 33000, France

Location

Hôpital de la Timone

Marseille, 13000, France

Location

Institut Curie

Paris, 75005, France

Location

IUCT Toulouse

Toulouse, 31100, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Hospital Universitari Vall d Hebrón

Barcelona, 08035, Spain

Location

Institut Català d Oncologia - Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Málaga - Hospital Civil

Málaga, 29010, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15076, Spain

Location

NHS Clatterbridge Cancer Center

Liverpool, L7 8YA, United Kingdom

Location

Aintree University Hospital NHS Fondation Trust

Liverpool, L9 7AL, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

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

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 3, 2019
• Study Start: December 12, 2019
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2031
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); ES (6); US (1); GB (2)