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Randomized Pre-surgical Window-of-Opportunity Trial of TTI-101 in Patients With Stage II-IV Resectable HPV-negative Squamous Cell Carcinoma of the Head and Neck

NCT05845307 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2025-12-08

No results posted yet for this study

Summary

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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Control Group

Given by PO

DRUG

TTI-101

Given by PO

Sponsors & Collaborators

  • Tvardi Therapeutics, Inc

    collaborator UNKNOWN

  • National Institutes of Health (NIH)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Andrew Sikora, MD,PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2025-11-13
Completion
2025-11-13
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845307 on ClinicalTrials.gov