Clinical Trials /

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

NCT04183166

Description:

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).

Related Conditions:
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Clinical Trial Evaluating TG4050 in Head and Neck Cancer
  • Official Title: A Randomized Phase I Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.

Clinical Trial IDs

  • ORG STUDY ID: TG4050.02
  • NCT ID: NCT04183166

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DrugSynonymsArms
TG4050Arm A : Early study treatment initiation

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Arm A : Early study treatment initiationExperimentalTG4050 treatment initiation at completion of primary treatment
  • TG4050
Arm B: Study treatment initiation at recurrenceExperimentalTG4050 treatment initiation at the time of recurrence
  • TG4050

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability (Adverse Event reported per CTCAE v5)
Time Frame:Up to 2 Years.
Safety Issue:
Description:Incidence of Adverse Event reported per CTCAE v5

Secondary Outcome Measures

Measure:Event-Free Survival duration
Time Frame:Up to 2 Years.
Safety Issue:
Description:Time from documented Complete Response after primary treatment to date of first recurrence
Measure:Tumor response rate
Time Frame:Up to 2 years.
Safety Issue:
Description:Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Transgene

Last Updated

January 7, 2020