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 (Jun 2026). This Phase 2/3 trial studies multiple treatments including Disitamab Vedotin and Cadonilimab for gastric cancer.
Treatment: Disitamab Vedotin · Cadonilimab · Paclitaxel — The 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT06221748 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate, anti-PD-1/PD-L1 inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression (IHC 1+, 2+, or 3+) is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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