Last updated 17 days ago

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

589 patients around the world

Available in Brazil, United States

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.

AstraZeneca

589Patients around the world

This study is for people with

Gastric cancer

Gastroesophageal cancer

Gastroesophageal adenocarcinoma

Requirements for the patient

To 130 Years

All Gender

Medical requirements

: 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 and the following requirement.
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 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.

: Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH plus.
Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
CNS metastases or CNS pathology including: epilepsy, seizures, aphasia, or stroke within 3 months prior to consent, severe brain injury, dementia, Parkinson's disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases.
Participant has known clinically significant corneal disease.
Persistent toxicities caused by previous anticancer therapy, excluding alopecia.
Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody.

SponsorAstraZeneca

Study typeInterventional

Conditions

Gastric cancerGastroesophageal adenocarcinoma

Requirements

To 130 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06346392