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

Last updated: April 8, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

Ramucirumab+ paclitaxel

Irinotecan

Paclitaxel

Clinical Study ID

NCT06346392
D9802C00001
2023-508276-11-00
  • Ages 18-130
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Capable of giving signed informed consent prior to any study procedure.

  2. Participant must be at least 18 years or the legal age of consent in thejurisdiction in which the study is taking place at the time of signing the ICF.

  3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinomaof gastric, GEJ, or distal esophagus (distal third of the esophagus) and thefollowing requirement:

(a) Participants with positive CLDN18.2 expression from archival tumor collectedwithin past 24 months or from a fresh biopsy.

  1. Disease progression on or after at least one prior line of treatment (LoT) foradvanced or metastatic disease, which included a fluoropyrimidine and a platinum,for advanced or metastatic disease.

  2. Must have at least one measurable or evaluable lesion assessed by the Investigatorbased on RECIST 1.1.

  3. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeksprior to baseline or day of first dosing.

  4. Predicted life expectancy of ≥ 12 weeks.

  5. Adequate organ and bone marrow function

  6. Body weight of ≥ 35 kg.

  7. Sex and Contraceptive Requirements

Exclusion

Exclusion Criteria:

  1. Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cellare considered positive by ISH). Participants must undergo local (or have had) HER2testing by IHC/ISH, and the most recent result of HER2 status will be used todetermine the eligibility.

  2. Participant has significant or unstable gastric bleeding and/or untreated gastriculcers.

  3. CNS metastases or CNS pathology including: epilepsy, seizures, aphasia, or strokewithin 3 months prior to consent, severe brain injury, dementia, Parkinson'sdisease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mentalillness, psychosis, CNS involvement of autoimmune diseases.

  4. Participant has known clinically significant corneal disease (eg, active keratitisor corneal ulcerations).

  5. Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy,excluding alopecia. Participants with irreversible toxicity that is not reasonablyexpected to be exacerbated by study intervention may be included (eg, hearing loss).

  6. Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatmentother than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy,multi-specific antibody including targeting CLDN18.2, etc).

Study Design

Total Participants: 589
Treatment Group(s): 7
Primary Treatment: Ramucirumab+ paclitaxel
Phase: 3
Study Start date:
March 04, 2024
Estimated Completion Date:
October 09, 2026

Study Description

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.

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