A Phase 3 interventional study of Sonesitatug vedotin and Rilvegostomig in Gastric Cancer, Gastroesophageal Junction Adenocarcinoma and Esophageal Cancer, sponsored by AstraZeneca. Recruiting at 311 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
The purpose of this Phase III study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in 1L CLDN18.2-positive, HER2-negative gastric, GEJ, and esophageal adenocarcinoma, and the clinical performance of the investigation in vitro diagnostics (IVDs). The study will include 2 cohorts to provide a treatment option for all participants that are HER2-negative and CLDN18.2-positive. Cohort 1 will evaluate sonesitatug vedotin in combination with rilvegostomig with capecitabine in participants who are CLDN18.2-positive and programmed death-ligand 1 (PD-L1) positive. Cohort 2 will evaluate sonesitatug vedotin in combination with capecitabine in participants who are CLDN18.2-positive and PD-L1 negative or immune checkpoint inhibitor (ICI) ineligible.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 2,130 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:
Exclusion Criteria:
Sonesitatug vedotin + Rilvegostomig + Capecitabine
Drug: Sonesitatug vedotin · Drug: Rilvegostomig · Drug: Capecitabine
Sonesitatug vedotin + Nivolumab + Capecitabine
Drug: Sonesitatug vedotin · Drug: Nivolumab · Drug: Capecitabine
Nivolumab + CAPOX OR Nivolumab + FOLFOX * nivolumab, capecitabine, oxaliplatin * nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin
Drug: Nivolumab · Drug: Capecitabine · Drug: 5-Fluorouracil · Drug: Oxaliplatin · Drug: Leucovorin
Sonesitatug vedotin + Capecitabine
Drug: Sonesitatug vedotin · Drug: Capecitabine
Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX: * zolbetuximab, capecitabine, oxaliplatin * zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin CAPOX or FOLFOX: * oxaliplatin, capecitabine, * 5-Fluorouracil, leucovorin, oxaliplatin
Drug: Capecitabine · Drug: 5-Fluorouracil · Drug: Oxaliplatin · Drug: Zolbetuximab · Drug: Leucovorin
Intravenous
Also known as: AZD0901
Intravenous
Also known as: AZD2936
Intravenous
Oral
Intravenous
Intravenous
Intravenous
Intravenous
Progression Free Survival (PFS) (Cohort 1 and Cohort 2)
PFS is defined as time from randomisation until progression per RECIST 1.1, or death due to any cause, whichever occurs first.
Time frame: Up to approximately 5 years
Overall Survival (OS) (Cohort 1)
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: Up to approximately 5 years
Overall Survival (OS) (Cohort 2)
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: Up to approximately 5 years
Overall Survival (OS) (Cohort 1)
OS is defined as time from randomisation until date of death due to any cause. Arm B versus C.
Time frame: Up to approximately 5 years
Progression Free Survival (PFS) (Cohort 1)
PFS is defined as time from randomisation until progression per RECIST 1.1 or death due to any cause, whichever occurs first. Arms B versus C.
Time frame: Up to approximately 5 years
Objective Response Rate (ORR) (Cohort 1 and Cohort 2)
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, per RECIST 1.1.
Time frame: Up to approximately 5 years
Duration of Response (DoR) (Cohort 1 and Cohort 2)
DoR (per RECIST 1.1) is derived for confirmed objective responses (CR or PR) only and is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of disease progression (ie, date of PFS event - date of first response + 1).
Time frame: Up to approximately 5 years
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2)
Pharmacokinetic parameters of sonesitatug vedotin (peak plasma concentration (Cmax))
Time frame: Up to approximately 5 years
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2)
Pharmacokinetic parameters of sonesitatug vedotin (trough plasma concentration (Cmin))
Time frame: Up to approximately 5 years
Immunogenicity of sonesitatug vedotin (Cohort 1 and Cohort 2)
Presence of ADAs for sonesitatug vedotin in serum (confirmatory results: positive or negative, titres).
Time frame: Up to approximately 5 years
Pharmacokinetics of rilvegostomig (Cohort 1)
Pharmacokinetic parameters of rilvegostomig (peak plasma concentration (Cmax))
Time frame: Up to approximately 5 years
Pharmacokinetics of rilvegostomig (Cohort 1)
Pharmacokinetic parameters of rilvegostomig (trough plasma concentration (Cmin))
Time frame: Up to approximately 5 years
Immunogenicity of rilvegostomig (Cohort 1)
Presence of ADAs for rilvegostomig in serum (confirmatory results: positive or negative, titres).
Time frame: Up to approximately 5 years
Safety and tolerability (Cohort 1 and Cohort 2)
Safety and tolerability as evaluated in terms of incidence of AEs and SAEs
Time frame: Up to approximately 5 years
Showing the first 100 of 311 sites across 24 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. 'Yes' indicates that AstraZeneca is accepting requests for IPD, but this does not mean that all requests will be shared.
Supporting information: Study protocol, Sap
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