A Phase 1b Study of CHS-114 and Toripalimab in People With Advanced Digestive Cancers

Full Title

A Phase 1b, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination with Toripalimab with or without Other Treatments in Participants with Advanced or Metastatic Solid Tumors

Purpose

Researchers are assessing different doses of CHS-114 when combined with toripalimab in people with advanced digestive cancers. The people in this study have digestive cancers that have metastasized (spread) or are inoperable (cannot be surgically removed). These cancers include:

  • Stomach (gastric) cancer
  • Gastroesophageal junction (GEJ) cancer
  • Esophageal cancer

CHS-114 helps the immune system fight cancer by targeting CCR8, a protein on immune cells called regulatory T cells (Tregs). Some tumors use Tregs that have CCR8 on them to block the immune system. CHS-114 finds and removes these CCR8-positive Tregs, allowing the immune system to recognize and destroy cancer cells.

Toripalimab works by removing the brakes on the immune system, helping it to target and destroy cancer cells. CHS-114 and toripalimab are given intravenously (by vein).

Who Can Join

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

  • Have inoperable or metastatic esophageal, gastric, or GEJ cancer.
  • Have recovered from the serious side effects of prior therapies before getting 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. Yelena Janjigian’s office at 646-888-4186.

Protocol

25-168

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06657144