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

Sponsor
RemeGen Co., Ltd.
Study ID
NCT06221748
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Disitamab Vedotin Injection — DRUG
    Phase II and III study ：2.5mg/kg, intravenous infusion，D1, every 2 weeks
  • Cadonilimab Injection — DRUG
    Phase II and III study ：6.0mg/kg, intravenous infusion，D1, every 2 weeks.
  • Paclitaxel Injection — DRUG
    Phase II and III study ：Calculate dosage based on body surface are,160mg/m2,intravenous infusion，D1,D8 every 3 weeks

Study Details

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.

Key Dates

First listed
Jan 24, 2024
Start date
Feb 22, 2024
Status verified
Jan 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Disitamab Vedotin + Cadonilimab
    Disitamab Vedotin With Cadonilimab
  • Experimental: Disitamab Vedotin
    Disitamab Vedotin arm
  • Experimental: Paclitaxel
    Paclitaxel Arm

Primary Outcome Measure

Objective remission rate (ORR) (Phase II) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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