ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase III • Oncology • NCT07431281.
- What is being tested: Sonesitatug vedotin (an antibody-drug conjugate targeting Claudin18.2) combined with capecitabine, with or without rilvegostomig (an ADAM10 inhibitor), as first-line treatment for advanced/metastatic gastric, GEJ, and esophageal adenocarcinomas that are Claudin18.2-positive and HER2-negative.
- Patient eligibility overview: Adults with previously untreated advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma confirmed to express Claudin18.2 and be HER2-negative, representing a molecularly-defined subset of this patient population.
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What This Trial Is Studying
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 Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.