Overview

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Status:
Recruiting
Trial end date:
2024-11-30
Target enrollment:
0
Participant gender:
All
Summary
This is a multicenter, open-label, two arms, randomized, phase I 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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Transgene
Criteria
Inclusion Criteria:

1. Signed written informed consent

2. Newly diagnosed stage III or IVA 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 cancer immunotherapy including anti-cancer vaccines, 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 within 30 days prior to TG4050 treatment
initiation

9. Uncontrolled intercurrent illness