AZD0901 for Stomach Cancer

Recruiting at 169 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, AZD0901, for individuals with advanced stomach cancer, specifically those with tumors expressing the CLDN18.2 protein. The main goal is to evaluate the effectiveness and safety of AZD0901 compared to other doctor-selected treatments. Participants will be divided into groups, with some receiving AZD0901 and others receiving standard therapies. The trial seeks individuals whose stomach cancer has worsened after at least one prior treatment and who have been informed that their cancer cannot be surgically removed or has spread. As a Phase 3 trial, this treatment represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that AZD0901 has been tested for safety in people with advanced stomach or gastro-esophageal junction cancer. Previous studies found that AZD0901 generally has a manageable safety profile, meaning most side effects are not severe and can be treated with medical care. Patients in these studies handled the treatment well, although some side effects may occur, as with any medication.

Since this trial is in a later phase, earlier studies have already provided some evidence of safety in humans. This indicates that AZD0901 has been tested enough to continue in the research process. However, participants should discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stomach cancer?

Unlike the standard treatments for stomach cancer, which typically involve chemotherapies or targeted therapies, AZD0901 is unique because it introduces a new mechanism of action. AZD0901 is administered through an intravenous infusion, and it specifically targets cancer cells in a novel way, which could enhance effectiveness and reduce side effects compared to traditional methods. Researchers are particularly excited about AZD0901 because it offers different dosing options, allowing for tailored treatment approaches (as seen in its two distinct dose levels), which may improve outcomes for patients battling this challenging condition.

What evidence suggests that AZD0901 might be an effective treatment for stomach cancer?

Research shows that AZD0901 has promising results for treating advanced stomach cancer. Studies have found that AZD0901 targets Claudin 18.2, a key protein in some stomach cancers, and has strong anti-tumor effects. In earlier trials, patients who received AZD0901 experienced a significant reduction in their tumors. The treatment is generally safe, with side effects that most patients can handle. In this trial, participants may receive AZD0901 at different dose levels or a regimen chosen by the investigator, including regionally accepted chemotherapies or targeted therapies. These findings suggest that AZD0901 could be an effective option for those with advanced stomach cancer that involves Claudin 18.2. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS507

CLARITY-Gastric 01: A randomized phase 3 study of ... All efficacy endpoints will assess the selected AZD0901 dose arm versus Arm 3. Safety and tolerability will be assessed in all pts who receive ≥ ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06219941

Study Details | NCT06219941 | AZD0901 in Participants ... The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204524006363

Claudin 18.2-targeting antibody–drug conjugate CMG901 ... CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer.

4. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D9800C00001

AZD0901 in participants with advanced solid tumours ... The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39788133/

Claudin 18.2-targeting antibody-drug conjugate CMG901 ... CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer.