A Phase 1 Study of TILT-123 Plus Avelumab in People With Advanced Solid Tumors

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Full Title

A Phase I Open-Label, Dose-Escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus TILT-123 in Combination with Avelumab in Injectable Solid Tumor Patients (Melanoma and SCCHN) Refractory to or Progressing After Anti-PD(L)1 Immunotherapy

Purpose

Researchers want to find the best dose of TILT-123 to give with avelumab to treat advanced solid tumors. The people in this study have squamous cell cancer of the head and neck, salivary gland cancer, thyroid cancer, or non-melanoma skin cancer. Their cancers keep growing even after treatment that included immunotherapy.

TILT-123 is made from an adenovirus (common cold virus). Researchers have removed or changed parts of the virus so it can only make copies of itself in cancer cells. TILT-123 kills cancer cells but not normal healthy cells. Avelumab is a drug that helps your immune system fight cancer. Avelumab is given intravenously (by vein). TILT-123 is given intravenously and directly injected into the tumor.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have squamous cell cancer of the head and neck, salivary gland cancer, thyroid cancer, or non-melanoma skin cancer.
  • Have cancer that came back or keeps growing even after treatment that included immunotherapy.
  • Have completed previous anti-cancer therapy at least 30 days before starting the study treatment.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Alan Ho’s office at 646-608-3774.

Protocol

23-235

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05222932