Overview
The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
Description
This is a Phase II, single arm, open label, multicentre study, assessing the efficacy and safety of AZD0901 in participants with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. The results of the study will provide clinical data on efficacy and safety of an innovation drug in Russian Federation.
Eligibility
Inclusion Criteria:
- Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus, with positive CLDN18.2 expression.
- Disease progression on or after at least one prior regimen for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
- Must have at least one measurable lesion assessed by the Investigator based on RECIST 1.1.
- ECOG performance status of 0 or 1.
- Minimum life expectancy of ≥12 weeks.
- Adequate organ and bone marrow function.
- Minimum body weight of 40 kg.
- Sex and Contraceptive Requirements.
Exclusion Criteria:
- Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH +.
- Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
- CNS metastases or CNS pathology.
- Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
- Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy.
- History of thromboembolic events.