Tongue Cancer Clinical Trial
Official title:
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)
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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