NCT05845307

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	Control Group	Given by PO
DRUG	TTI-101	Given by PO

Timeline

• Start date: 2025-06-20
• Primary completion: 2025-11-13
• Completion: 2025-11-13
• First posted: 2023-05-06
• Last updated: 2025-12-08

Regulatory

• FDA-regulated drug study