A Phase I Study of AM0010 in Patients with Advanced Solid Tumors

Protocol
13-224
Full Title
A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, and Pharmacokinetics of AM0010 in Patients with Advanced Solid Tumors
Phase
I
Purpose

The purpose of this study is to find the highest dose of the investigational drug AM0010 that can be given safely in patients with metastatic melanoma, prostate cancer, ovarian cancer, kidney cancer, colorectal cancer, lung cancer, and pancreatic cancer.

AM0010 works by stimulating the immune system to fight cancer. It is a manmade version of a natural immune protein called interleukin-10 (IL-10), which is involved in regulating the immune system and inflammation in the body. It is hoped that AM0010 can trigger an immune response against cancer cells.

AM0010 is given as a daily injection under the skin.

Investigator
Autio, Karen, MD
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have melanoma, prostate cancer, ovarian cancer, kidney cancer, colorectal cancer, lung cancer, or pancreatic cancer that has spread (metastasized) to other organs.
  • Patients should have recovered from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact the Immunotherapeutics Clinic at 646-888-3359.

Disease(s)
Colorectal Cancer
Kidney Cancer
Lung Cancer
Melanoma
Ovarian Cancer
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Upper Gastrointestinal: Pancreatic Cancer
Locations