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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Hôpital Saint André - CHU de Bordeaux
Bordeaux, France
Hôpital de la Timone
Marseille, France
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)
Incidence of Adverse Event reported per CTCAE v5.
Time frame: Up to 2 Years.
Phase I/II: Disease-Free Survival
Time from randomization to documented recurrence of disease.
Time frame: Up to 2 years.
Phase I: Disease-Free Survival
Time from randomization to documented recurrence of disease.
Time frame: Up to 2 Years.
Phase I: Tumor response rate
Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria.
Time frame: Up to 2 years.
Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)
Incidence of Adverse Event reported per CTCAE v5.
Time frame: Up to 2 years.
Phase I/II: Distant Metastases-Free Survival
Time from randomization to documented first occurrence of distant metastasis.
Time frame: Up to 2 years.
Phase I/II: Loco-Regional Relapse-Free Survival
Time from randomization to documented loco-regional recurrence.
Time frame: Up to 2 years.
Phase I/II: Overall Response Rate in patients with recurrent disease
Percentage of patients with a best overall response of complete response or partial response according to RECIST, version 1.1 criteria.
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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
...and 4 more locations
Time frame: Up to 2 years.