2130 Participants NeededMy employer runs this trial

Sonesitatug Vedotin + Capecitabine for Stomach Cancer

Recruiting at 243 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of a new treatment combination for certain types of advanced stomach cancer. Researchers are testing how well sonesitatug vedotin (an experimental treatment) works with capecitabine, sometimes adding other drugs like rilvegostomig or nivolumab. The study targets individuals with advanced gastric, gastroesophageal, or esophageal cancer that hasn't been treated before and who have a specific protein (CLDN18.2) present in their cancer. Participants should not have a history of HER2-positive cancer and must meet other health criteria. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

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 the combination of sonesitatug vedotin and capecitabine is generally well-tolerated by patients with advanced stomach cancer. Previous studies found that this treatment can be administered safely, with most side effects being manageable. Some patients experienced common side effects like nausea and tiredness, but serious side effects were rare.

For the combination of sonesitatug vedotin with nivolumab and capecitabine, studies indicate that this mix is also well-tolerated. Common side effects include tiredness and mild skin reactions. These side effects are typical with cancer treatments and are closely monitored by doctors.

In the group receiving sonesitatug vedotin, rilvegostomig, and capecitabine, research suggests this treatment is generally safe. Few serious side effects have been reported, with most issues being mild, such as tiredness and mild digestive problems.

Overall, these treatments have shown promising safety in earlier studies. However, participants should always discuss potential risks with their healthcare providers.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for stomach cancer because they introduce unique combinations and mechanisms. Sonesitatug Vedotin is an antibody-drug conjugate, which means it delivers chemotherapy directly to cancer cells, potentially reducing side effects and improving effectiveness compared to traditional chemotherapy. The combination of Sonesitatug Vedotin with Capecitabine, and additional drugs like Rilvegostomig and Nivolumab in some arms, offers a multifaceted approach that targets cancer cells more precisely. This approach could provide a significant advantage over standard treatments like CAPOX or FOLFOX, which are broader in scope. By harnessing targeted therapy, these treatments may offer better outcomes and fewer side effects for patients.

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

Research has shown that the drug sonesitatug vedotin, when combined with capecitabine, may help treat stomach cancer. In a study with 109 patients, about 29% experienced tumor shrinkage. Participants in Arm D of the trial will receive the combination of sonesitatug vedotin and capecitabine.

Participants in Arm B will receive sonesitatug vedotin, capecitabine, and nivolumab, which boosts the immune system. Previous studies have shown that adding nivolumab to this treatment improves survival rates and slows cancer growth. Specifically, when nivolumab was combined with other drugs, the one-year survival rate increased to 26.2% from 10.9% in similar cancers. These findings suggest that these drug combinations can be effective against gastric cancer.13456

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic stomach, gastroesophageal junction, or esophageal adenocarcinoma that tests positive for Claudin18.2 and negative for HER2. Participants must not have had prior treatment for this cancer, need to be in good general health, and meet certain lab criteria.

Inclusion Criteria

My PD-L1 status has been tested and I am eligible for immunotherapy.
Body weight ≥ 35 kg
Minimum life expectancy of ≥ 12 weeks
See 8 more

Exclusion Criteria

I need IV nutrition because my stomach or intestines are blocked.
Cardiac abnormalities as outlined in the protocol
I do not have active or uncontrolled hepatitis or poorly controlled HIV.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sonesitatug vedotin in combination with capecitabine with or without rilvegostomig, or other treatment regimens based on cohort assignment

Up to approximately 5 years

Follow-up

Participants are monitored for safety, efficacy, and survival outcomes after treatment

Up to approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Capecitabine
  • Rilvegostomig
  • Sonesitatug Vedotin

Trial Overview

The study is testing a new drug called sonesitatug vedotin combined with capecitabine, with or without another drug called rilvegostomig. The goal is to see how well these combinations work as first-line treatments compared to other standard therapies.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Active Control

Group I: Arm DExperimental Treatment2 Interventions
Group II: Arm BExperimental Treatment3 Interventions
Group III: Arm AExperimental Treatment3 Interventions
Group IV: Arm CActive Control5 Interventions
Group V: Arm EActive Control5 Interventions

Find a Clinic Near You

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

Study Details | NCT07431281 | Sonesitatug Vedotin in ...

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in ...

Sonesitatug Vedotin in Combination With Capecitabine With ...

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without ...

Sonesitatug Vedotin + Capecitabine for Stomach Cancer

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in ...

Health Technology Briefing September 2025

Sonesitatug vedotin is in development for the second-line or greater treatment of metastatic or locally advanced unresectable gastric cancer (GC) or ...

A randomized phase 3 study of sonesitatug vedotin (sone ...

Prognosis is poor in GC GEJC; median overall survival (OS) is less than 10 months in the 2L setting and less than 6 months in the 3L+ setting (Wilke H, et al.

NCT07069712 | A Study of Novel Agents or Combinations ...

GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations ...