A Phase 1/2 Study of STAR0602 in People With Solid Tumors


Full Title

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that are Antigen-rich (START-001)


Researchers in this study want to find the best dose of STAR0602 to use in people with advanced solid tumors. The people in this study have cancer that is inoperable (cannot be taken out with surgery) or metastatic (has spread). STAR0602 boosts the immune system to stop tumor growth. It is given intravenously (by vein).

STAR0602 is a bifunctional antibody-fusion molecule. Bifunctional means STAR0602 has two arms that can attach to different proteins on the surface of cancer cells. When STAR0602 binds to these proteins, this interaction causes your body’s own T cells to attack the cancer cells. T cells are part of the immune system. They help protect your body from infection and help your body fight against cancer.

Who Can Join

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

  • Have metastatic or inoperable cervical cancer, head and neck cancer, or cancer that has a high number of genetic mutations and cannot be treated with standard therapies.
  • Have recovered from the serious side effects of previous treatments before getting STAR0602.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.


For more information or to see if you can join this study, please call Dr. Claire Friedman’s office at 646-888-4593.




Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory



ClinicalTrials.gov ID