A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519787-40-00

Enrollment

126

Registered

2026-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer Expressing Claudin18.2, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Brief summary

Progression Free Survival (PFS) per RECIST 1.1 (Cohort 1 and Cohort 2), Overall Survival (OS) (Cohort 1 )

Detailed description

Overall Survival (OS) (Cohort 2), Overall Survival (OS) (Cohort 1 Arm B and C), Progression Free Survival (PFS) per RECIST 1.1 (Cohort 1 Arm B and C), Objective Response Rate (ORR) per RECIST 1.1 (Cohort 1 and Cohort 2), Duration of Response (DoR) per RECIST 1.1 (Cohort 1 and Cohort 2), Concentration of sonesitatug vedotin, total antibody and MMAE in serum and PK parameters (Cohort 1 and Cohort 2), Concentration of rilvegostomig in serum and PK parameters (Cohort 1), Presence of ADAs for sonesitatug vedotin (Cohort 1 and Cohort 2), Presence of ADAs for rilvegostomig (Cohort 1), Incidence of AEs and SAEs, changes from baseline in vital signs, clinical laboratory results, and ECGs (Cohort 1 and Cohort 2)

Interventions

DRUGOxaliplatin Bendalis 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGMycofit

DRUG250 mg

DRUGkapsułki twarde

DRUGAZD0901

DRUGInflectra 100 mg powder for concentrate for solution for infusion

DRUGOPDIVO 600 mg solution for injection

DRUGBENDAFOLIN 10 mg/ml Injektionslösung

DRUGVyloy 100 mg powder for concentrate for solution for infusion.

DRUGRilvegostomig

DRUGCapecitabine Accord 150 mg film-coated tablets

DRUGFluorouracil 50 mg/ml Solution for Injection or Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) per RECIST 1.1 (Cohort 1 and Cohort 2), Overall Survival (OS) (Cohort 1 )	—

Secondary

Measure	Time frame
Overall Survival (OS) (Cohort 2), Overall Survival (OS) (Cohort 1 Arm B and C), Progression Free Survival (PFS) per RECIST 1.1 (Cohort 1 Arm B and C), Objective Response Rate (ORR) per RECIST 1.1 (Cohort 1 and Cohort 2), Duration of Response (DoR) per RECIST 1.1 (Cohort 1 and Cohort 2), Concentration of sonesitatug vedotin, total antibody and MMAE in serum and PK parameters (Cohort 1 and Cohort 2), Concentration of rilvegostomig in serum and PK parameters (Cohort 1), Presence of ADAs for sonesitatug vedotin (Cohort 1 and Cohort 2), Presence of ADAs for rilvegostomig (Cohort 1), Incidence of AEs and SAEs, changes from baseline in vital signs, clinical laboratory results, and ECGs (Cohort 1 and Cohort 2)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 18, 2026