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OncoMatch/Clinical Trials/NCT06221748

DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

Is NCT06221748 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Disitamab Vedotin and Cadonilimab for gastric cancer.

Phase 2/3RecruitingRemeGen Co., Ltd.NCT06221748Data as of May 2026

Treatment: Disitamab Vedotin · Cadonilimab · PaclitaxelThe purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Esophageal Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression (IHC 1+, 2+, or 3+) (IHC 1+, 2+, or 3+)

Confirmation of HER2 (IHC 1+, 2+, or 3+)

Required: PD-L1 (CD274) expression

Confirmation of...PD-L1 expression

Disease stage

Metastatic disease required

Locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology and/or cytology

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: standard first-line therapy — advanced/metastatic

Subjects will only have failed or been intolerant to prior standard first-line therapy (excluding paclitaxel)

Cannot have received: antibody-drug conjugate (Disitamab Vedotin)

prior treatment with any antibody-drug conjugate including Disitamab Vedotin For Injection

Cannot have received: anti-PD-1/PD-L1 inhibitor (cadonilimab)

prior treatment with cardinolizumab

Lab requirements

Blood counts

Hemoglobin ≥ 9 g/dL (no transfusion/erythropoietin within 2 weeks); ANC ≥ 1.5 × 10^9/L (no G-CSF within 2 weeks); Platelets ≥ 90 × 10^9/L (no platelet transfusion/thrombopoietin within 2 weeks)

Kidney function

Blood creatinine ≤ 1.5x ULN, or CrCl ≥ 60 mL/min

Liver function

Serum total bilirubin ≤ 1.5x ULN; ALT and AST ≤ 2.5x ULN (≤ 5x ULN with hepatic metastases)

Cardiac function

NYHA <3; LVEF ≥ 50%

Bone marrow function: Hemoglobin ≥ 9 g/dL... Platelet count ≥ 90 × 10^9/L... Liver function: Serum total bilirubin ≤ 1.5x ULN... ALT and AST ≤ 2.5x ULN (≤ 5x ULN with hepatic metastases)... Renal function: Blood creatinine ≤ 1.5x ULN, or CrCl ≥ 60 mL/min... Cardiac function: NYHA <3; LVEF ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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