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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Voluntarily agreed to participate in the study and signed an informed consent form;

Age 18-75 years(both 18 and 75);

Expected survival ≥ 12 weeks

ECOG physical condition score of 0 or 1

Disqualifiers

Metastatic CNS and/or meningeal carcinomatosis;

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

Prior anti-cancer therapy resulting in toxicity that has not recovered to CTCAE (version 5.0) ≤ Grade 1 (except for hair loss, hyperpigmentation, or other conditions that do not increase the risk of the subject's use of the drug determined by the investigators;

Radical radiotherapy within 3 months prior to study dosing; palliative radiotherapy 2 weeks prior to dosing is permitted, at a dose that meets local diagnostic criteria for palliative care and with radiotherapy coverage of less than 30% of the bone marrow area;

Trial design

Treatments tested in this trial

  • Disitamab Vedotin Injection
  • Cadonilimab Injection
  • Paclitaxel Injection

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators