TLR8 Agonist VTX-2337 and Cyclophosphamide in Treating Patients With Metastatic, Persistent, Recurrent, or Progressive Solid Tumors

Summary

This phase Ib trial studies the best way of TLR8 Agonist VTX-2337 and cyclophosphamide in treating patients with a solid tumor that has spread from the primary site (place where it started) to other places in the body (metastatic), progressed for a long time (persistent), come back (recurrent), or is growing, spreading, or getting worse (progressed). TLR8 Agonist VTX-2337 may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TLR8 Agonist VTX-2337 together with cyclophosphamide may be a better treatment for solid tumors.

Conditions

• Colorectal Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma
• Recurrent Breast Carcinoma
• Recurrent Colorectal Carcinoma
• Recurrent Melanoma of the Skin
• Recurrent Non-Small Cell Lung Carcinoma
• Recurrent Pancreatic Carcinoma
• Recurrent Renal Cell Carcinoma
• Solid Neoplasm
• Stage IV Breast Cancer
• Stage IV Non-Small Cell Lung Cancer
• Stage IV Renal Cell Cancer
• Stage IV Skin Melanoma
• Stage IVA Colorectal Cancer
• Stage IVA Pancreatic Cancer
• Stage IVB Colorectal Cancer
• Stage IVB Pancreatic Cancer

Interventions

DRUG

Cyclophosphamide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pegfilgrastim

Given SC

OTHER

Pharmacological Study

Correlative studies

DRUG

TLR8 Agonist VTX-2337

Given SC

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Peter Cohen · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-05

Primary Completion

2016-09-26

Completion

2017-06-01

Countries

• United States

Study Locations