This is a multicenter, randomized, controlled, open-label, Phase III study, designed to evaluate the efficacy and safety of JS107 versus investigator-selected therapy in the second-line or later treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2.
The study population consists of patients with CLDN18.2-positive, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy. The primary endpoints of the study are BICR-assessed progression-free survival and overall survival.
Number of subjects and allocation:This study plans to enroll approximately 560 subjects, who will be randomized in a 1:1 ratio to receive either JS107 (experimental group) or investigator-selected therapy (control group).
Voluntarily participate in this study, have ICF signed after sufficient informed consent, and have good compliance.
Age ≥ 18 years, male or female.
ECOG PS 0 or 1.
Expected survival period≥ 3 months.
Previous treatment with any drug or cellular therapy targeting CLDN18.2 (except CLDN18.2 monotarget monoclonal antibody).
Previously treated with an ADC loaded with a tubulin inhibitor.
Received strong CYP3A inhibitor or inducer within 2 weeks or 5 half-lives prior to randomization, whichever is longer.
Use of chemotherapy, immunotherapy or other anti-tumor therapies or participation in other clinical trials within 3 weeks prior to randomization, or use of oral fluorouracil, small molecule targeted drugs or traditional Chinese medicine for gastric cancer within 2 weeks prior to randomization.
Parallel
JS107 for Injection
DrugSubjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
Irinotecan
DrugSubjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
Paclitaxel
DrugSubjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
Docetaxel
DrugSubjects who are confirmed to meet the inclusion and exclusion criteria after screening will be randomly assigned in a 1:1 ratio to receive JS107 treatment (experimental group) or investigator's chosen treatment (control group) until the criteria for terminating the study treatment as specified in the protocol are met (including subjects experiencing BICR-confirmed radiological PD, death, loss to follow-up, withdrawal of informed consent, or termination of the study by the sponsor, whichever occurs first).
BICR-PFS
Progression-Free Survival (BICR-PFS) evaluated based on Blinded Independent Central Review (BICR) (according to the RECIST v1.1 criteria)
Overall Survival
The primary endpoint of overall survival (OS) in this multicenter, randomized, open-label Phase III study is the time from randomization to death from any cause, aiming to compare the benefit between JS107 and investigator's choice of therapy in patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy.
INV-PFS
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
BICR-ORR or INV-ORR
ORR evaluated by investigators or BICR (according to the RECIST v1.1 criteria)
BICR-DCR or INV -DCR
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
BICR-DoR or INV -DoR
DoR (based on the RECIST v1.1 criteria) evaluated by investigators or BICR
HRQOL
HRQOL (based on FACT-Ga and EORTC QLQ-C30 questionnaires)
expression levels of CLDN18.2
Detect different expression levels of CLDN18.2 in tumor tissues and analyze the correlation with therapeutic efficacy
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