Clinical Trials Directory

Trials / Completed

CompletedNCT01334177

TLR8 Agonist VTX-2337 and Cetuximab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Squamous Cell Cancer of Head and Neck

Phase I Clinical Trial of VTX-2337, a Small Molecule Toll-Like Receptor 8 (TLR8) Agonist in Combination With Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinomas of the Head and Neck (SCCHN)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
13 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best dose of TLR8 Agonist VTX-2337 when given together with cetuximab in treating patients with locally advanced, recurrent, or metastatic squamous cell cancer of the head and neck (SCCHN). Biological therapies, such as TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving TLR8 Agonist VTX-2337 together with cetuximab may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety, tolerability and to assess the dose-limiting toxicities (DLT) of VTX-2337 (TLR8 Agonist VTX-2337) when given in conjunction with cetuximab in order to define the maximum tolerated dose (MTD)/recommended phase II dose (RP2D). SECONDARY OBJECTIVES: I. To determine the pharmacodynamic immune response to VTX-2337 in combination with cetuximab. II. Correlative assessments of immunologic response and activity will be performed, including: Quantitative evaluation of baseline immune status via in-vitro assessment of cytokine and chemokine response to immunostimulatory agents; quantitative assessment of plasma cytokines, chemokines, and other inflammatory markers via protein array; quantitative assessment of natural killer (NK) cells via flow cytometry; quantitative assessment of antigen-specific responses in cytokine-producing cells to common prognostic SCCHN antigens via interferon (INF)gamma-enzyme-linked immunosorbent spot (ELISpot). III. To assess whether subjects with functional genetic variations in the TLR8 and FC-gamma-R IIIA genes have altered biological and/or clinical responses to VTX-2337, genetic characterization of subjects will be performed via standard genotyping assays. TERTIARY OBJECTIVES: I. To assess preliminary evidence of anti-tumor activity for the combination of VTX-2337 and cetuximab, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. OUTLINE: This is a dose-escalation study of TLR8 Agonist VTX-2337. Patients receive cetuximab intravenously (IV) over 60-120 minutes on days -28, -21, -14, -7 of weeks -4 to -1. Patients then receive cetuximab IV on days 1, 8, 15, and 22 and TLR8 agonist VTX-2337 subcutaneously (SC) on days 1, 8, 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 28 days.

Conditions

Interventions

TypeNameDescription
DRUGTLR8 agonist VTX-2337Given SC
BIOLOGICALcetuximabGiven IV
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacogenomic studiesCorrelative studies

Timeline

Start date
2011-06-01
Primary completion
2014-06-01
First posted
2011-04-13
Last updated
2015-03-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01334177. Inclusion in this directory is not an endorsement.