🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07431281
Recruiting Phase 3

Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

NCT07431281 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-02-03
Last updated
2026-09-09

Condition(s) studied

Gastric CancerGastroesophageal Junction AdenocarcinomaEsophageal Cancer

Investigational drug(s) / intervention(s)

Sonesitatug vedotinRilvegostomigNivolumabCapecitabine5-FluorouracilOxaliplatinZolbetuximabLeucovorin

Sonesitatug vedotin: Intravenous

Rilvegostomig: Intravenous

Nivolumab: Intravenous

Capecitabine: Oral

5-Fluorouracil: Intravenous

Oxaliplatin: Intravenous

Zolbetuximab: Intravenous

Leucovorin: Intravenous

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Capable of giving signed informed consent * Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. * Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma * Positive CLDN18.2 expression, as determined prospectively by central IHC testing * Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below: 1. Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement. 2. Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible * ECOG performance status of 0 or 1 with no deterioration to \> 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation. * Minimum life expectancy of ≥ 12 weeks. * At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1. * Adequate organ and bone marrow function as specified in the protocol * Body weight ≥ 35 kg. * Sex and contraceptive requirements Exclusion Criteria: * Known HER2-positive status * Significant or unstable gastric bleeding and/or untreated gastric ulcers. * Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded. * CNS pathology * Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain. * Require parenteral nutrition support due to gastric or gastrointestinal obstruction. * Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening. * Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline. * Cardiac abnormalities as outlined in the protocol * Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation. * Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled * Known partial or total DPD enzyme deficiency

Primary outcome measure(s)

Trial sites (311)

FacilityCityRegionStatus
Research Site Birmingham Alabama Not Yet Recruiting
Research Site Mobile Alabama Not Yet Recruiting
Research Site Anchorage Alaska Not Yet Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Springdale Arkansas Not Yet Recruiting
Research Site Duarte California Not Yet Recruiting
Research Site Fountain Valley California Not Yet Recruiting
Research Site Fullerton California Not Yet Recruiting
Research Site Irvine California Not Yet Recruiting
Research Site La Jolla California Not Yet Recruiting
Research Site Los Alamitos California Not Yet Recruiting
Research Site Orange California Not Yet Recruiting
Research Site Walnut Creek California Recruiting
Research Site Denver Colorado Not Yet Recruiting
Research Site Lone Tree Colorado Recruiting
Research Site New Haven Connecticut Withdrawn
Research Site Newark Delaware Not Yet Recruiting
Research Site Washington D.C. District of Columbia Withdrawn
Research Site Fort Myers Florida Withdrawn
Research Site Jacksonville Florida Recruiting
Research Site Orlando Florida Not Yet Recruiting
Research Site St. Petersburg Florida Withdrawn
Research Site West Palm Beach Florida Withdrawn
Research Site Atlanta Georgia Recruiting
Research Site Atlanta Georgia Not Yet Recruiting
Research Site Atlanta Georgia Withdrawn
Research Site Macon Georgia Not Yet Recruiting
Research Site Newnan Georgia Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Niles Illinois Recruiting
Research Site Zion Illinois Not Yet Recruiting
Research Site Indianapolis Indiana Not Yet Recruiting
Research Site Waukee Iowa Not Yet Recruiting
Research Site Lexington Kentucky Not Yet Recruiting
Research Site Louisville Kentucky Not Yet Recruiting
Research Site Silver Spring Maryland Not Yet Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Burlington Massachusetts Not Yet Recruiting
Research Site Worcester Massachusetts Withdrawn
Research Site Grand Rapids Michigan Recruiting

+ 271 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07431281 on ClinicalTrials.gov ↗ ← All trials in the USA