AZD0901 for Stomach Cancer

Recruiting at 145 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Disqualifiers: HER2 positive, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 90

Duration: Approximately 3 years

572 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the purpose of this trial?

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

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.

Inclusion Criteria

I have a tumor that can be measured or evaluated.

My body weight is at least 35 kg.

Predicted life expectancy of ≥ 12 weeks

Exclusion Criteria

My cancer is HER2 positive, confirmed by specific tests.

I have a significant eye condition affecting my cornea.

I have had brain metastases or brain-related issues in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD0901 or Investigator's choice of therapy as 2L+ treatment for advanced or metastatic gastric or GEJ adenocarcinoma

Approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Follow-up for 90 days post treatment completion

Treatment Details

Interventions

• AZD0901

Trial Overview 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.

Participant Groups

Group I: AZD0901 arm 1 Experimental Treatment 1 Intervention

Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.

Group II: AZD0901 Arm 2 Experimental Treatment 1 Intervention

Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed)

Group III: Investigator's choice arm Active Control 6 Interventions

Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology