A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Transgene

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Drug: TG4050

Study type: Interventional

Funder types: Industry

Identifiers

NCT04183166

TG4050.02

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Arm A : Early study treatment initiation

Experimental group

Description:

TG4050 treatment initiation at completion of primary treatment

Treatment:

Drug: TG4050

Arm B: Study treatment initiation at recurrence

Experimental group

Description:

TG4050 treatment initiation at the time of recurrence

Treatment:

Drug: TG4050