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
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)
Progression Free Survival (PFS) (Cohort 1 and Cohort 2) — Up to approximately 5 years PFS is defined as time from randomisation until progression per RECIST 1.1, or death due to any cause, whichever occurs first.
Overall Survival (OS) (Cohort 1) — Up to approximately 5 years OS is defined as the time from randomisation until the date of death due to any cause.
Trial sites (311)
Facility
City
Region
Status
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.
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