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TTI-101 for Head and Neck Cancer
Phase < 1
Waitlist Available
Led By Andrew Sikora, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a drug can reduce cancer growth in the head/neck before surgery.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of TTI-101 aren't listed here, similar drugs may cause allergic reactions, liver issues (as indicated by eligibility criteria), fatigue, digestive problems, blood disorders, increased risk of infection, and potential heart complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control Group
2012
Completed Phase 2
~2470
TTI-101
2023
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,578 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,212 Total Patients Enrolled
Tvardi Therapeutics, IncUNKNOWN
1 Previous Clinical Trials
47 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My high blood pressure is not under control.My cancer is a stage II-IV squamous cell carcinoma of the head or neck.I have not had signs of infection in the last 2 weeks.I have not had severe infections in the last 4 weeks.I have not received a live vaccine in the last 30 days.I haven't had cancer treatment in the last 3 weeks.I haven't had any treatments for head or neck cancer in the last 4 months.I have active tuberculosis.I have not had major surgery in the last 28 days.I have a history of serious heart problems.I have been treated with a STAT inhibitor for my current cancer.My oropharyngeal cancer is not linked to HPV.I am scheduled for surgery to remove my cancer, possibly followed by radiation.I have another cancer that has been treated or progressed in the last 3 years.I am 18 years old or older.I don't have any health issues that would prevent me from taking a new drug.My cancer has not spread to distant parts of my body.I agree to follow the study's rules for using birth control.I am a woman who meets specific health conditions.I am fully active or can carry out light work.My blood, liver, and kidney test results are within normal ranges.I have not had a stroke or similar event in the last 2 years.I can swallow pills.I am not currently on medications like bisphosphonates for high calcium levels.My cancer can be measured by scans or physical exams.I do not have active Hepatitis B, C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: TTI-101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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