A Phase 3 Study of AZD0901 Versus Standard Therapy to Treat Advanced Stomach or Gastroesophageal Junction Cancer With Claudin18.2

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Full Title

A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (CLARITY-Gastric 01) (WIRB)

Purpose

Researchers are comparing AZD0901 with standard treatments in people with advanced gastric cancer. The people in this study have cancer of the stomach or the junction between the esophagus and stomach (gastroesophageal junction). The people in this study have cancers that make a protein called Claudin18.2 (CLDN18.2).

If you join this study, you will be randomly assigned to get one of these treatments:

  • AZD0901 alone
  • A standard therapy for your cancer, such as ramucirumab, paclitaxel, docetaxel, irinotecan, or TAS-102.

Who Can Join

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

  • Have advanced cancer of the stomach or gastroesophageal junction which keeps growing after treatment and makes CLDN18.2.
  • Have recovered from the serious side effects of previous treatments 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 or to see if you can join this study, please call Dr. Yelena Janjigian’s office at 646-888-4286.

Protocol

25-008

Phase

Phase III (phase 3)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06346392