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Monoclonal Antibodies

AZD0901 for Stomach Cancer

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years).
Awards & highlights

Summary

This trial aims to compare the effectiveness and safety of AZD0901 with other treatment options for patients with advanced stomach or gastroesophageal junction cancer that has spread, and that expresses a specific protein

Who is the study for?
This trial is for adults with advanced or metastatic stomach or gastroesophageal junction cancer that expresses a protein called Claudin18.2, who have already tried at least one other treatment. Participants should not be receiving other cancer treatments and must have adequate organ function.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of AZD0901 against standard therapies chosen by the investigator, such as TAS-102, Docetaxel, Paclitaxel, Apatinib, Ramucirumab with Paclitaxel, or Irinotecan in patients with certain types of stomach cancers.See study design
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues like nausea, fatigue, hair loss (with some drugs), lowered blood cell counts leading to increased infection risk or bleeding problems. The exact side effects will depend on the specific therapy received.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS) for 3L+ participants
Progression Free Survival (PFS) in all randomized participants
Secondary outcome measures
Duration of Response (DoR) in all randomized participants
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs
ORR for 3L+ participants
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: AZD0901 arm 1Experimental Treatment1 Intervention
Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.
Group II: AZD0901 Arm 2Experimental Treatment1 Intervention
Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment.
Group III: Investigator's choice armActive Control6 Interventions
Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,624,010 Total Patients Enrolled
~393 spots leftby Apr 2026