TG4050 for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on another investigational agent, you may need to stop that treatment.
How is the drug TG4050 different from other treatments for head and neck cancer?
Are You a Good Fit for This Trial?
Adults with newly diagnosed stage III or IVA squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx who are in complete response after primary tumor treatment. Participants must be generally healthy with an ECOG performance status of 0 or 1 and have proper organ function. Excluded are those with other active cancers, prior cancer immunotherapies, HIV/AIDS, hepatitis infections, pregnant/nursing women, and recent involvement in other drug trials.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TG4050 treatment either at completion of primary treatment or at the time of recurrence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TG4050
Find a Clinic Near You
Who Is Running the Clinical Trial?
Transgene
Lead Sponsor