A Phase 1a/2 Study of GI-102 Immunotherapy in People With Advanced Sarcoma

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Full Title

An open-label, multicenter, dose escalation and expansion phase 1/2 study to evaluate the safety, tolerability and pharmacokinetics, and anti-cancer activity of GI-102, a CD80-IgG4 Fc-IL-2v bispecific fusion protein, as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan in patients with advanced or metastatic solid tumors (MK3474-G08)

Purpose

Researchers want to find the best dose of GI-102 for treating advanced sarcoma. The people in this study have sarcoma that has spread.

GI-102 works by boosting the power of your immune system to find and kill cancer cells. It takes the brakes off the immune response by blocking a protein called CTLA-4. GI-102 increases the number of immune cells through a second protein called IL-2. It is given intravenously (by vein).

Who Can Join

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

  • Have sarcoma that has spread beyond its original location.
  • Have recovered from the serious side effects of prior therapies.
  • 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 or to see if you can join this study, please call Dr. Viswatej Avutu’s office at 646-888-6860.

Protocol

24-094

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT05824975