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).
Patients with HER2 negative G/GEJ adenocarcinoma confirmed by histology/cytology. who have received at one prior line of systemic treatment and developed PD, and the previous treatment must include fluorouracil and platinum; CLDN18.2-positive, HER2-negative.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
560
Subjects 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).
Subjects 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).
Subjects 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).
Subjects 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).
AnHui Provincial Cancer Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGClinical Oncology School of Fujian Medical University, Fujian Cancer Hospital
Fuzhou, Fujian, China
BICR-PFS
Progression-Free Survival (BICR-PFS) evaluated based on Blinded Independent Central Review (BICR) (according to the RECIST v1.1 criteria)
Time frame: up to 2 years
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.
Time frame: up to 5 years
INV-PFS
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
Time frame: up to 2 years
BICR-ORR or INV-ORR
ORR evaluated by investigators or BICR (according to the RECIST v1.1 criteria)
Time frame: up to 2 years
BICR-DCR or INV -DCR
Progression-Free Survival evaluated by investigators (INV-PFS, according to the RECIST v1.1 criteria)
Time frame: up to 2 years
BICR-DoR or INV -DoR
DoR (based on the RECIST v1.1 criteria) evaluated by investigators or BICR
Time frame: up to 2 years
The incidence rate and severity of AE
The incidence and severity of adverse events (AEs) evaluated according to the NCI-CTC AE v5.0 standard
Time frame: up to 2 years
Valley concentration of JS107
Valley concentration of JS107 (including ADC, total antibody, and toxin)
Time frame: up to 2 years
anti-drug antibodies (ADA) for JS107
Incidence and titer of anti-drug antibodies (ADA) for JS107 (including ADC, total antibody, and toxin)
Time frame: up to 2 years
Incidence of neutralizing antibodies (NAb) to JS107
Incidence of neutralizing antibodies (NAb) to JS107 (including ADC, total antibody, and toxin)
Time frame: up to 2 years
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Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGGansu Provincial Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGGansu wuwei tumor hospital
Wuwei, Gansu, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGNanfang hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITING...and 58 more locations