A Phase 2 Study of AZD0901 Alone and With Anti-Cancer Drugs in People With Solid Tumors That Make Claudin 18.2

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Full Title

A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Tumours Expressing Claudin 18.2

Purpose

Researchers want to see how well AZD0901 works against digestive cancers. It will be given alone and with other anti-cancer drugs. The people in this study have advanced cancers of the stomach, gastroesophageal junction, or pancreas.

In addition, their cancers make a protein called claudin (CLDN) 18.2, which plays a role in tumor growth. AZD0901 binds to cancer cells that make this protein.

If you join this study, you will get AZD0901 alone or with standard chemotherapy. The standard chemotherapy drugs include 5-FU, leucovorin, irinotecan, and gemcitabine. The treatments in this study are given intravenously (by vein).

Who Can Join

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

  • Have gastric, gastroesophageal junction, or pancreatic cancer that has spread and makes CLDN 18.2.
  • 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 or to see if you can join this study, please call Dr. Yelena Janjigian’s office at 646-888-4186.

Protocol

24-161

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06219941