TTI-101 for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAndrew Sikora, MD,PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?To learn if TTI-101 can reduce the growth of HPV-negative squamous cell carcinomas of the head and neck when given before standard of care surgery.

Eligibility Criteria

This trial is for adults with Stage II-IV HPV-negative squamous cell carcinoma of the head and neck, who can swallow pills, have no distant metastases, and are planning surgery as primary therapy. Participants must not be pregnant or breastfeeding and agree to use contraception. They should have adequate organ function and no recent vaccines or major surgeries.

Inclusion Criteria

My cancer is a stage II-IV squamous cell carcinoma of the head or neck.

My oropharyngeal cancer is not linked to HPV.

I am scheduled for surgery to remove my cancer, possibly followed by radiation.

+12 more

Exclusion Criteria

My high blood pressure is not under control.

I have not had signs of infection in the last 2 weeks.

I have not had severe infections in the last 4 weeks.

+16 more

Participant Groups

The study tests TTI-101's effectiveness in reducing tumor growth before standard surgery compared to a control group receiving no TTI-101. It's a randomized trial where patients are assigned by chance to either receive TTI-101 or be in the control group prior to their planned surgical treatment.

2Treatment groups

Experimental Treatment

Group I: TTI-101Experimental Treatment1 Intervention

Participants you will be randomly assigned to either receive the study drug or be in a control group.

Group II: Control GroupExperimental Treatment1 Intervention

Participants you will be randomly assigned to either receive the study drug or be in a control group.