A Phase 2 Study of AZD0901 and Rilvegostomig Plus Standard Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer

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Full Title

A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Purpose

Researchers want to see if combining AZD0901 and rilvegostomig with standard chemotherapy works well in people with gastric or gastroesophageal junction (GEJ) cancer. GEJ cancer occurs where the esophagus joins the stomach.

The people in this study have gastric or GEJ cancer that is inoperable (cannot be taken out) or metastasized (spread). In addition, their cancers make a protein called claudin (CLDN) 18.2.

If you take part in this study, you will get AZD0901 and rilvegostomig with either 5-fluorouracil or capecitabine. Capecitabine is taken orally (by mouth) and the other drugs are given intravenously (by vein).

[QUESTION: IS MSK ONLY PARTICIPATING IN SUBSTUDY 4?]

Who Can Join

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

  • Have inoperable or metastatic gastric or GEJ cancer that has not yet been treated.
  • 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 646-888-4286.

Protocol

25-113

Phase

Phase II (phase 2)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05702229