Adults with advanced and/or metastasized solid tumors who failed usual chemotherapy treatment are invited to be in a research study testing the immunotherapy drug

UVA Tracking #
HSR200293
Principal Investigator
Linda R Duska
Contact
Anne Gabel
Contact Email
Contact Phone
434.982.6657
Official Trial Title
A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced/Metastatic Solid Tumors
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who fall into one of the following groups:
o Group A (cutaneous/subcutaneous) will include the following tumor-specific cohorts:
? Squamous cell carcinomas of the head and neck (SCCHN)
? Dermatological
? Genitourinary/gynecological
? Gastrointestinal
? Other cutaneous/subcutaneously accessible solid tumors
o Group B: visceral lesions accessible by ultrasound/CT guidance

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 best tolerated dose is identified, it will be used to evaluate if the treatment causes tumors to shrink in participants.

You will be in the study for roughly 29 weeks (or about 6.5 months). This includes about 4 weeks for screening, 8 weeks of treatment, and 17 weeks of follow up. You may be on treatment longer, if your doctor deems you are receiving benefit. So the length of time you are in the study, and total number of visits, will depend on how you respond to the treatment.

Reimbursement: Up to $175 per night for a hotel

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT03954067

Compensation

Compensation: $50 per completed visit

Visitor Guidelines

Clinics & COVID-19 Patients: No Visitors 

For adult clinic appointments or those in the hospital with COVID-19:

  • No one can come with you into clinic buildings
  • No visitors at the bedside of COVID-19 cases
  • The care team can allow standard exceptions 

In Hospital, ED, & Procedures: 1 Visitor

For adults in the hospital, emergency department, or having medical procedures:

  • Only 1 visitor allowed at a time
  • Two visitors can be designated
  • The care team can allow standard exceptions

Virtual Options: Connect From a Distance

When you can't visit in person, you can still:

Visitor Guidelines

Clinics & COVID-19 Patients: No Visitors 

For adult clinic appointments or those in the hospital with COVID-19:

  • No one can come with you into clinic buildings
  • No visitors at the bedside of COVID-19 cases
  • The care team can allow standard exceptions 

In Hospital, ED, & Procedures: 1 Visitor

For adults in the hospital, emergency department, or having medical procedures:

  • Only 1 visitor allowed at a time
  • Two visitors can be designated
  • The care team can allow standard exceptions

Virtual Options: Connect From a Distance

When you can't visit in person, you can still: