AZD0901 for Stomach Cancer

Recruiting at 52 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must not be taking: QT prolonging drugs, CYP3A4 inhibitors

Disqualifiers: Peptic ulcer, CNS metastases, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 11 weeks

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called AZD0901 for individuals with certain types of advanced cancers. The study evaluates the safety and effectiveness of AZD0901, both alone and in combination with other cancer treatments. The trial includes three groups: one for stomach cancer, one for pancreatic cancer, and one for biliary tract cancer. Individuals with advanced or metastatic cancer who have specific markers, such as CLDN18.2, and have undergone limited previous treatments might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing access to potentially effective new therapies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that certain medications, like those that prolong the QT/QTc interval or affect specific enzymes, may not be allowed. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

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

Research has shown that AZD0901, when used alone, has a safety profile that patients with advanced stomach or esophagus cancer can handle well. Most patients managed the treatment without major issues, and while some side effects occurred, they were manageable.

In studies where AZD0901 was combined with other cancer drugs, patients also experienced manageable side effects. This suggests that the treatment is generally well-tolerated when used with other therapies.

For those considering joining a trial with AZD0901, these findings offer some reassurance about its safety. However, as with any treatment, individual reactions may vary, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

AZD0901 is unique because it offers a new approach to treating cancers like stomach, pancreatic, and biliary tract cancer by potentially enhancing the effectiveness of existing chemotherapy agents or working on its own. Unlike standard treatments that often focus on killing cancer cells directly, AZD0901 may work by targeting specific pathways that help cancer cells grow and survive, potentially leading to better outcomes. Researchers are excited because this could mean more effective treatment options with fewer side effects, giving patients a better quality of life.

What evidence suggests that this trial's treatments could be effective for stomach cancer?

Research has shown that AZD0901 targets a protein called Claudin 18.2, often found in stomach cancer cells. Early results suggest this could help stop tumor growth. Studies on similar treatments, such as the drug CMG901, have shown promising results in shrinking tumors in patients with advanced stomach cancer. These findings offer hope that AZD0901 might also effectively treat stomach cancer, as it works similarly. While more information is needed, these early signs are encouraging for those seeking new treatment options. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced stomach or gastroesophageal cancers that express CLDN18.2 can join this trial. They must have a measurable tumor, be in good physical condition, and expected to live at least 12 weeks. Participants should not have severe neuropathy, active ulcers or bleeding, lung inflammation history, brain metastases, certain heart risks or other cancers.

Inclusion Criteria

I have had no more than 2 treatments for my cancer that cannot be surgically removed.

My organs and bone marrow are working well.

My cancer is advanced or has spread beyond the stomach or gastroesophageal junction.

Exclusion Criteria

My cancer has spread to my brain.

I do not have moderate or severe numbness, tingling, or pain in my hands or feet.

I have conditions that could affect my heart's rhythm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD0901 monotherapy or in combination with anti-cancer agents

11 weeks

Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• AZD0901

Trial Overview AZD0901 is being tested alone and with cancer drugs like Nanoliposomal Irinotecan and Gemcitabine for safety and effectiveness against tumors expressing CLDN18.2. The study will also look at how the body processes these drugs and if they cause immune reactions.

How Is the Trial Designed?

Group I: Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER Experimental Treatment 1 Intervention

Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.

Group II: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA Experimental Treatment 7 Interventions

Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents

Group III: Sub Study 1 - AZD0901 MONOTHERAPY Experimental Treatment 1 Intervention

Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.

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. 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.

3. 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 ...

4. 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.

5. 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 ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS3163

CLARITY-PanTumor01: A phase 2 trial of the claudin 18.2- ... Here we describe an ongoing, Phase 2 study of AZD0901 in patients with CLDN18.2-expressing advanced solid tumors, including G/GEJ cancer and PDAC.

7. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=22194&isClinicalTrial=True

ANZCTR - Registration To investigate the safety and tolerability, of AZD0901 monotherapy or in combination with anti-cancer agents in particpants with advanced or metastatic solid ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666379124004312

CMG901, a Claudin18.2-specific antibody-drug conjugate ... CMG901 is a Claudin18.2-specific ADC. CMG901 kills tumor cells via direct cytotoxicity, ADCC, CDC, and bystander killing effects.