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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 | Clinical Trials | Clareo Health

WITHDRAWNEARLY_PHASE1

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•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Detailed Description

Objectives: Primary: • To determine the change in pY-STAT3 H-score in tumor tissue in post-treatment resection specimens versus pre-treatment biopsy specimens. Secondary: * To determine the safety and tolerability of pre-surgery TTI-101 in patients with Stage II-IV HPV-negative HNSCC who are planned for definitive local surgery with or without radiation. * To determine the individual pre/post treatment changes in pY-STAT3 H-scores in epithelial and stromal tumor cells. * To determine the pathologic response rate to pre-surgery TTI-101. * To determine the overall response rate (ORR) to pre-surgery TTI-101 using RECIST v1.1 criteria. * To determine the disease free, disease specific and overall survival (DFS, DSS, OS) after pre-surgery TTI-101 treatment and SOC surgery. Exploratory: * To evaluate the effects of pre-surgery TTI-101 on circulating and tumor-infiltrating immunocytes, and on the intratumoral expression of PD-1 along with other immune related molecules. * To compare outcome measures (response rate and survival) in control versus TTI-101-treated patients. * To determine the association of immunologic changes with treatment response. * To determine the association of pharmacokinetic (PK) measures with treatment response.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•Surgical resection must be planned as primary therapy with or without adjuvant radiation therapy.
•Signed Informed Consent Form (ICF).
•Ability and willingness to comply with the requirements of the study protocol.
•Ability to swallow study drug.
•Age years of 18 years.
•Measurable disease per RECIST v1.1 (see Appendix 2) and/or per direct clinical measurements.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix 4)
+16 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from study entry.
•Any prior systemic or radiotherapy within the last 4 months directed towards the squamous cell carcinoma of the head and neck that is to be resected as part of SOC therapy.
•Standard of care anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, for concurrent malignancy or unresected squamous cell carcinoma of the head and neck within 3 weeks prior to initiation of study treatment.
•AEs from prior anticancer therapy that have not resolved to Grade 1 except for alopecia, Grade 2 neuropathy or endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement are eligible
•Pregnancy, lactation, or breastfeeding
•Inability to comply with study and follow-up procedures
•Has a known active Hepatitis B (defined as Hepatitis B RNA detected) or known active Hepatitis C virus (defined as HCV RNA is detected) infection, or known active HIV (defined as HIV RNA is detected) infection.
•Active tuberculosis
•Severe infections within 4 weeks prior to treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
•Signs or symptoms of infection as determined by the treating team within 2 weeks prior to treatment
+18 more criteria

Key Dates

Start Date

June 20, 2025

Primary Completion Date

November 13, 2025

Completion Date

November 13, 2025

Last Updated

December 8, 2025

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Control Group

DRUG

TTI-101

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers

A Study of MGC026 in Participants With Advanced Solid Tumors

Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers

5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC

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