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.
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
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;
Parallel
Disitamab Vedotin Injection
DrugPhase II and III study ：2.5mg/kg, intravenous infusion，D1, every 2 weeks
Cadonilimab Injection
DrugPhase II and III study ：6.0mg/kg, intravenous infusion，D1, every 2 weeks.
Paclitaxel Injection
DrugPhase II and III study ：Calculate dosage based on body surface are,160mg/m2,intravenous infusion，D1,D8 every 3 weeks
Objective remission rate (ORR) (Phase II)
ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Percentage of Participants With Adverse Events (AEs)(Phase II)
Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0
Progression-Free Survival(PFS) （IRC）（ Phase III)
PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)
Overall Survival (OS)(Phase III)
OS was defined as the time from the date of randomization to the date of death from any cause.
Progression-Free Survival(PFS)（investigator）(Phase II and Phase III)
PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)
Overall Survival (OS)(Phase II)
OS was defined as the time from the date of randomization to the date of death from any cause.
Objective remission rate (ORR) （investigator） (Phase III)
ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Disease Control Rate (DCR) (Phase II and Phase III)
Percentage of patients with complete response, partial response, or stable disease for a certain period of time according to RECIST v1.1.
Click on the lead sponsor to view all of their trials.
