Clinical Trial: NHS-IL12 for Solid Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: First In-Human Phase I Trial of NHS-IL12 in Patients With Metastatic Solid Tumors

Brief Summary:

Background:

- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment.

Objectives:

- To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments.

Eligibility:

- Individuals at least 18 years of age with solid tumors that have not responded to standard treatments.

Design:

  • Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
  • Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests.
  • Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles....