DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy
NCT06221748 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2024-04-03
Summary
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.
Conditions
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
Interventions
- DRUG
-
Disitamab Vedotin Injection
Phase II and III study :2.5mg/kg, intravenous infusion,D1, every 2 weeks
- DRUG
-
Cadonilimab Injection
Phase II and III study :6.0mg/kg, intravenous infusion,D1, every 2 weeks.
- DRUG
-
Paclitaxel Injection
Phase II and III study :Calculate dosage based on body surface are,160mg/m2,intravenous infusion,D1,D8 every 3 weeks
Sponsors & Collaborators
-
RemeGen Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianmin Fang, Ph.D · RemeGen Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-22
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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