TTI-101 for Head and Neck Cancer

Overseen By Andrew Sikora, MD,PHD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antibiotics, Immunosuppressants

Disqualifiers: Pregnancy, Active infections, Cardiac issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

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.

Research Team

Andrew Sikora, MD,PHD

Principal Investigator

M.D. Anderson Cancer Center

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Treatment

Participants receive TTI-101 to assess its effect on tumor growth before standard of care surgery

4-6 weeks

Surgery

Participants undergo standard of care surgery with or without radiation

Follow-up

Participants are monitored for safety, effectiveness, and survival outcomes after treatment and surgery

12 months

Treatment Details

Interventions

• Control Group
• TTI-101

Trial Overview 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.

Participant Groups

Group I: TTI-101 Experimental Treatment 1 Intervention

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

Group II: Control Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Tvardi Therapeutics, Inc

Collaborator

Trials

2

Recruited

80+