AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 18 Years - anyAllAstraZeneca
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 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, โ‰ฅ CTCAE Grade 2 at screening. * Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade โ‰ค 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 โ‰ฅ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled * Known partial or total DPD enzyme deficiency
๐Ÿ’Š

What it tests

  • Sonesitatug vedotin
  • Rilvegostomig
  • Nivolumab
  • Capecitabine
  • 5-Fluorouracil
๐Ÿ“

Where

314 sites
Research Site
Birmingham, United States
Research Site
Mobile, United States
Research Site
Anchorage, United States
Research Site
Phoenix, United States
Research Site
Springdale, United States
Research Site
Duarte, United States
Research Site
Fountain Valley, United States
Research Site
Fullerton, United States

โ€ฆand 306 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy