A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Phase 1

Recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck
• Interventions: Drug: TG4050

• Registration Number: NCT04183166
• Lead Sponsor: Transgene

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-03
• Study Start: 2019-12-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: Study treatment initiation at recurrence	TG4050	TG4050 treatment initiation at the time of recurrence
Arm A : Early study treatment initiation	TG4050	TG4050 treatment initiation at completion of primary treatment

Primary Outcome Measures

Name	Time	Method
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)	Up to 2 Years.	Incidence of Adverse Event reported per CTCAE v5.
Phase I/II: Disease-Free Survival	Up to 2 years.	Time from randomization to documented recurrence of disease.

Secondary Outcome Measures

Name	Time	Method
Phase I/II: Distant Metastases-Free Survival	Up to 2 years.	Time from randomization to documented first occurrence of distant metastasis.
Phase I: Tumor response rate	Up to 2 years.	Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria.
Phase I/II: Overall Response Rate in patients with recurrent disease	Up to 2 years.	Percentage of patients with a best overall response of complete response or partial response according to RECIST, version 1.1 criteria.
Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)	Up to 2 years.	Incidence of Adverse Event reported per CTCAE v5.
Phase I: Disease-Free Survival	Up to 2 Years.	Time from randomization to documented recurrence of disease.
Phase I/II: Loco-Regional Relapse-Free Survival	Up to 2 years.	Time from randomization to documented loco-regional recurrence.

Trial Locations

Locations (14)

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

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

Hospital Regional Universitario de Málaga - Hospital Civil; 🇪🇸 Málaga, Spain

NHS Clatterbridge Cancer Center; 🇬🇧 Liverpool, United Kingdom

Aintree University Hospital NHS Fondation Trust; 🇬🇧 Liverpool, United Kingdom

Institut Català d Oncologia - Hospital Duran i Reynals; 🇪🇸 Barcelona, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain