Sonesitatug Vedotin + Capecitabine for Stomach Cancer

Recruiting at 201 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: HER2-positive, Autoimmune disorders, CNS pathology, 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: Unknown

Duration: Up to approximately 5 years

2130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

Are You a Good Fit for This Trial?

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

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.

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

How Is the Trial Designed?

Group I: Arm D Experimental Treatment 2 Interventions

Sonesitatug vedotin + Capecitabine

Group II: Arm B Experimental Treatment 3 Interventions

Sonesitatug vedotin + Nivolumab + Capecitabine

Group III: Arm A Experimental Treatment 3 Interventions

Sonesitatug vedotin + Rilvegostomig + Capecitabine

Group IV: Arm C Active Control 5 Interventions

Nivolumab + CAPOX OR Nivolumab + FOLFOX * nivolumab, capecitabine, oxaliplatin * nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin

Group V: Arm E Active Control 5 Interventions

Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX: * zolbetuximab, capecitabine, oxaliplatin * zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin CAPOX or FOLFOX: * oxaliplatin, capecitabine, * 5-Fluorouracil, leucovorin, oxaliplatin

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