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AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Status
Active
Cancer Type
Esophogeal Cancer
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 - 130 Years, Male and Female
Study Type
Treatment
NCT ID
NCT06346392
Protocol IDs
D9802C00001 (primary)
NCI-2024-05552
Study Sponsor
AstraZeneca Pharmaceuticals LP

Summary

The purpose of this study is to measure the efficacy and safety of AZD0901 compared to
Investigator's choice of therapy as 2L+ treatment for participants with advanced or
metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

Objectives

This is a Phase III, multi-center, open-label, sponsor-blinded, randomized, global study
to assess the efficacy and safety of AZD0901 compared to Investigator's choice of therapy
as the 2L+ treatment for participants with advanced or metastatic gastric or GEJ
adenocarcinoma expressing CLDN18.2, and the clinical performance of the investigational
IVD. As part of this combined approach, the efficacy analyses from this study will also
provide the basis to evaluate the clinical performance of Ventana CLDN18.2 assay as an
IVD device for the identification of patients with advanced or metastatic gastric or GEJ
adenocarcinoma expressing CLDN18.2 who may benefit from AZD0901.

Eligibility

  1. Capable of giving signed informed consent prior to any study procedure.
  2. Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.
  3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement: (a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.
  4. Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
  5. Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.
  6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
  7. Predicted life expectancy of = 12 weeks.
  8. Adequate organ and bone marrow function
  9. Body weight of = 35 kg.
  10. Sex and Contraceptive Requirements

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 101 and Suite 102
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers (NGOC) - Cobb Hospital (Marietta)


340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101


Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.