A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus,Administered by Intratumoral Injection as a Single Agent and in Combination withPembrolizumab in Subjects withAdvanced/Metastatic Solid Tumors
A Study of ASP9801 in Patients With Advanced Metastatic Solid Tumors
Sponsor: Astellas Pharma Global Development, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAT3966
U.S. Govt. ID: NCT03954067
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The goal of this study is to determine at what dose the study treatment (ASP9801) is safe and tolerated in study participants with cancer who have tumors that cannot be removed (unresectable) or have spread (metastasized) to a different part of the body. This will be done by enrolling small groups of participants to receive different doses of the study treatment, starting with a very small dose and gradually increasing. The dose amount you receive will depend on the group you are assigned to. When the safe dose is identified, it will be used to evaluate if the treatment causes tumors to shrink in participants. During this period, participants will be continuously assessed to determine if ASP9801 is safe and tolerated by participants taking it. ASP9801 will be given by an injection directly into the tumor. Cancers include: Bladder cancer, colon cancer, rectal cancer, cervical cancer, skin cancer, melanoma, prostate cancer, stomach cancer, and testicular cancer.
This study is closed
Investigator
Matthew Ingham, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Do you have a predicted life expectancy of greater than 12 weeks? Yes No
Do you have a diagnosis of cancer that cannot be removed (unresectable) or has spread? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162