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A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2
A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2

NCT07143604

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Gastric Cancer, Gastroesophageal Junction Cancer

Interventions: AZD0901

Countries: Russia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (13)
  • Chelyabinsk, Russia
  • Krasnoyarsk, Russia
  • Kuzmolovskiy, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Nizhny Novgorod, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia
  • Volgograd, Russia