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
Esophogeal Cancer
Stomach/ Gastric Cancer
Unknown Primary
18 - 130 Years, Male and Female
D9802C00001 (primary)
NCI-2024-05552
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
- Capable of giving signed informed consent prior to any study procedure.
- 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.
- 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.
- 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.
- Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.
- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Predicted life expectancy of = 12 weeks.
- Adequate organ and bone marrow function
- Body weight of = 35 kg.
- Sex and Contraceptive Requirements
Treatment Sites in Georgia
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101
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