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Unknown

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
Patients must meet the following criteria for study entry: Biopsy-proven primary Stage II-IV squamous cell carcinoma of the head and neck
For oropharyngeal cancer patients: HPV-negative by p16 and/or direct high-risk HPV assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a stage II-IV squamous cell carcinoma of the head or neck.
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My oropharyngeal cancer is not linked to HPV.
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I am scheduled for surgery to remove my cancer, possibly followed by radiation.
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I am 18 years old or older.
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My cancer has not spread to distant parts of my body.
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My cancer can be measured by scans or physical exams.
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I am fully active or can carry out light work.
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My blood, liver, and kidney test results are within normal ranges.
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I can swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,555 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,748 Total Patients Enrolled
Tvardi Therapeutics, IncUNKNOWN
1 Previous Clinical Trials
47 Total Patients Enrolled

Media Library

Control Group (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05845307 — Phase < 1
Squamous Cell Carcinoma Research Study Groups: Control Group, TTI-101
Squamous Cell Carcinoma Clinical Trial 2023: Control Group Highlights & Side Effects. Trial Name: NCT05845307 — Phase < 1
Control Group (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05845307 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively recruiting participants?

"According to clinicaltrials.gov, this treatment trial is no longer accepting patients; the posting was initially published on October 31st 2023 and edited most recently on April 25th 2023. Although this research has concluded enrollment, there are presently 2713 other trials in search of participants."

Answered by AI
~22 spots leftby Feb 2025