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Clinical Trials in the USA / NCT06346392
Active, not recruiting Phase 3

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

NCT06346392 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-03-04
Last updated
2026-07-09

Condition(s) studied

Gastric CancerGastroesophageal Junction Cancer

Investigational drug(s) / intervention(s)

AZD0901AZD0901Ramucirumab+ paclitaxelPaclitaxelDocetaxelIrinotecanTAS-102Apatinib

AZD0901: Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV

AZD0901: Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)

Ramucirumab+ paclitaxel: Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W

Paclitaxel: Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)

Docetaxel: Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)

Irinotecan: Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W

TAS-102: TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China)

Apatinib: Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)

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

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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 the jurisdiction in which the study is taking place at the time of signing the ICF. 3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement: (a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy. 4. Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease. 5. Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1. 6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. 7. Predicted life expectancy of ≥ 12 weeks. 8. Adequate organ and bone marrow function 9. Body weight of ≥ 35 kg. 10. Sex and Contraceptive Requirements 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/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine the eligibility. 2. Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers. 3. CNS metastases or CNS pathology including: epilepsy, seizures or aphasia 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. 4. Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations). 5. Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected 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 treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc). 7. History of thromboembolic events: 1. Participants with venous thromboembolism within the past 6 months prior to randomization: participants with venous port or catheter thrombosis or superficial venous thrombus that do not require treatment or are stable on treatment with anticoagulants are excepted 2. History of arterial thromboembolism within the past 12 months prior to randomization 8. As judged by the Investigator, any evidence of diseases which in the Investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

Primary outcome measure(s)

Trial sites (158)

FacilityCityRegionStatus
Research Site Mobile Alabama
Research Site Tucson Arizona
Research Site Duarte California
Research Site Irvine California
Research Site Los Angeles California
Research Site Los Angeles California
Research Site Newport Beach California
Research Site Washington D.C. District of Columbia
Research Site Hollywood Florida
Research Site Orlando Florida
Research Site Marietta Georgia
Research Site Boise Idaho
Research Site Lexington Kentucky
Research Site Boston Massachusetts
Research Site Ann Arbor Michigan
Research Site Ann Arbor Michigan
Research Site Kansas City Missouri
Research Site Mineola New York
Research Site New York New York
Research Site New York New York
Research Site New York New York
Research Site Philadelphia Pennsylvania
Research Site York Pennsylvania
Research Site Charlottesville Virginia
Research Site Fredericksburg Virginia
Research Site Olympia Washington
Research Site Ribeirão Preto Brazil
Research Site São Paulo Brazil
Research Site Vitória Brazil
Research Site Barrie Ontario
Research Site London Ontario
Research Site North York Ontario
Research Site Ottawa Ontario
Research Site Toronto Ontario
Research Site Montreal Quebec
Research Site Beijing China
Research Site Changchun China
Research Site Chengdu China
Research Site Chengdu China
Research Site Fuzhou China

+ 118 more sites — see the full list on the official registry below.

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06346392 on ClinicalTrials.gov ↗ ← All trials in the USA