NCT02166255

APN401 in Treating Patients With Melanoma, Kidney Cancer, Pancreatic Cancer, or Other Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery

A Phase 1, Open-Label, Dose-Ranging Study to Assess the Safety and Immunologic Activity of APN401

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401) in treating patients with melanoma, kidney, or pancreatic cancer, or other solid tumors that have spread to other parts of the body or that cannot be removed by surgery. There are factors in immune cells in the blood that inhibit their ability to kill cancers. Treating white blood cells with one of these factors in the laboratory may help the white blood cells kill more cancer cells when they are put back in the body.

Detailed description

PRIMARY OBJECTIVES: I. To determine the toxicities and establish the maximal tolerated dose (MTD) of APN401. II. To determine the effects of APN401 on immune response. SECONDARY OBJECTIVES: I. To document clinical response and survival. OUTLINE: This is a dose-escalation study. Patients receive autologous siRNA-transfected peripheral blood mononuclear cells APN401 intravenously (IV) over 30 minutes for 1 course in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually for 1 year.

Conditions

• Recurrent Melanoma
• Recurrent Pancreatic Cancer
• Recurrent Renal Cell Cancer
• Stage III Pancreatic Cancer
• Stage III Renal Cell Cancer
• Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
• Stage IV Melanoma
• Stage IV Pancreatic Cancer
• Stage IV Renal Cell Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	siRNA-transfected peripheral blood mononuclear cells APN401	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-06-18
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study