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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,130
Intravenous
Intravenous
Intravenous
Oral
Intravenous
Intravenous
Intravenous
Intravenous
Research Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Springdale, Arkansas, United States
NOT_YET_RECRUITINGResearch Site
Duarte, California, United States
NOT_YET_RECRUITINGResearch Site
La Jolla, California, United States
NOT_YET_RECRUITINGProgression 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
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Los Alamitos, California, United States
NOT_YET_RECRUITINGResearch Site
Orange, California, United States
NOT_YET_RECRUITINGResearch Site
Walnut Creek, California, United States
NOT_YET_RECRUITINGResearch Site
Denver, Colorado, United States
NOT_YET_RECRUITINGResearch Site
Lone Tree, Colorado, United States
NOT_YET_RECRUITINGResearch Site
New Haven, Connecticut, United States
WITHDRAWN...and 248 more locations