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

AstraZeneca

Status and phase: Enrolling; Phase 2

Conditions: Gastroesophageal Junction Cancer; Gastric Cancer

Treatments: Drug: AZD0901

Study type: Interventional

Funder types: Industry

Identifiers

NCT07143604

AZ-RU-00007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

AZD0901

Experimental group

Description:

Participants will receive AZD0901 IV, Q3W

Treatment:

Drug: AZD0901