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Comparing AZD0901 to standard treatments for advanced gastric cancer

A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared With Investigator's Choice of Therapy in Second- or Later-Line Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (CLARITY Gastric 01)

Phase 3 Interventional AstraZeneca · NCT06346392

This study is testing if a new treatment called AZD0901 can work better than standard therapies for patients with advanced gastric cancer that has progressed after previous treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment572 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR-T
Locations186 sites (Birmingham, Alabama and 185 other locations)
Trial IDNCT06346392 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of AZD0901 against the investigator's choice of therapy for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that expresses CLDN18.2. The study is multi-center, open-label, and randomized, aiming to provide insights into the clinical performance of the Ventana CLDN18.2 assay as an in vitro diagnostic device. Participants must have experienced disease progression after at least one prior treatment line and have measurable lesions. The trial will help determine if AZD0901 offers a better treatment option for eligible patients.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma expressing CLDN18.2.

Not a fit: Patients who have not expressed CLDN18.2 or who have not progressed after prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced gastric cancer who express CLDN18.2.

How similar studies have performed: Other studies have shown promise in targeting CLDN18.2 in gastric cancer, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 185 other locations

+136 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastric CancerGastroesophageal Junction CancerGastric cancerGastroesophageal junction cancerPhase IIIClaudin 18.2AZD0901
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.