A Phase 1 Study of TTI-101 in People With Advanced Liver Cancer

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Full Title

A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants with Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma

Purpose

Researchers want to find the best dose of TTI-101 that can be used safely alone and with other drugs for cancer. The people in this study have hepatocellular carcinoma (liver cancer) that has metastasized (spread) or is inoperable (surgically unremovable).

TTI-101 blocks a protein called STAT3 from telling cancer cells to grow and spread. It may also improve the power of immunotherapy drugs (treatment that boosts the body’s natural defenses to fight cancer).

If you join this study, you will get one of these treatments:

  • TTI-101 alone
  • TTI-101 with pembrolizumab immunotherapy
  • TTI-101 with atezolizumab immunotherapy and bevacizumab

TTI-101 is taken orally (by mouth) and the other drugs are given intravenously (by vein).

Who Can Join

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

  • Have metastatic or inoperable hepatocellular carcinoma.
  • Have completed any prior liver cancer treatment at least 4 weeks before getting the study therapy.
  • 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. James Harding’s office at 646-888-4314.

Protocol

23-335

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

ClinicalTrials.gov ID

NCT05440708