About Shanghai GOBROAD Cancer Hospital
As a specialized oncology research hospital, China Pharmaceutical University Affiliated Shanghai GOBROAD Cancer Hospital upholds the dual commitment of putting patient needs first while advancing scientific innovation. Leveraging the university's high-caliber talent development and frontier scientific research capabilities, the hospital centers its clinical research efforts around Principal Investigators (PIs), continuously improving the efficiency and quality of clinical studies and accelerating the translation of innovative biomedical achievements to create more hope for patients.
The hospital is currently conducting a Phase 3 clinical trial titled "A Multicenter, Randomized, Controlled, Open-Label Phase 3 Study Evaluating the Efficacy and Safety of JS107 Versus Investigator's Choice of Therapy as Second-Line or Later Treatment for CLDN18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma."
This clinical trial has received approval from the National Medical Products Administration (NMPA) and the Ethics Committee of Shanghai GOBROAD Cancer Hospital. Patient recruitment is now underway on a voluntary participation basis.
Investigational Drug: JS107
The active ingredient of JS107 is a recombinant humanized anti-CLDN18.2 monoclonal antibody-MMAE (monomethyl auristatin E) conjugate. CLDN18.2 (Claudin 18.2) is a tight junction protein highly expressed on the surface of gastric cancer cells but with limited expression in normal tissues, making it an ideal target for antibody-drug conjugate (ADC) therapy. By binding to CLDN18.2, JS107 delivers the potent cytotoxic payload MMAE directly into tumor cells, offering a promising new therapeutic approach for patients with CLDN18.2-positive gastric malignancies.
Key Inclusion Criteria
Patients must meet all of the following major criteria to be considered for enrollment:
- Aged 18 years or older at the time of signing informed consent;
- Histologically or cytologically confirmed HER2-negative locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma;
- CLDN18.2 positivity confirmed by central laboratory testing;
- Good performance status (ECOG 0-1);
- Previously received at least one line of systemic therapy with documented disease progression; prior therapy must have included fluoropyrimidine and platinum agents. If disease recurred within 6 months after completion of adjuvant or neoadjuvant therapy, this is considered failure of first-line treatment;
- At least one measurable lesion according to RECIST v1.1 assessment criteria;
- Adequate major organ function, without severe cardiovascular or cerebrovascular disease, active infection, or uncontrolled thoracic or abdominal effusion;
- Willing and able to comply with the study protocol requirements.
Whether you meet the eligibility criteria will be determined based on comprehensive examination results and evaluation by the study physician.
Study Design Overview
This is a multicenter, randomized, controlled, open-label Phase 3 clinical study. Eligible patients will be randomly assigned to receive either JS107 or investigator's choice of standard therapy. The study aims to evaluate whether JS107 provides superior efficacy compared to existing treatment options in this patient population with limited therapeutic choices after failure of prior lines of therapy.
The primary endpoint focuses on progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), and safety tolerability.
About the Principal Investigator
Prof. Zhou Jun (周俊)
Vice President and Director, Department of Digestive Oncology
Shanghai GOBROAD Cancer Hospital (China Pharmaceutical University Affiliated)
Former Chief Physician, Tongji University Affiliated Shanghai East Hospital
Clinic Schedule: Every Tuesday Morning
Chief Physician, Master's Supervisor
Specialization: Prof. Zhou focuses on digestive system malignancies, with expertise in gastric cancer, colorectal cancer, and hepatobiliary and pancreatic malignancies. His clinical and research interests include cell therapy, molecular targeted therapy, immunotherapy, and clinical trials of novel anticancer therapeutics.
Learn More or Enroll
If you are interested in learning more details about this clinical trial or other advanced treatment options at GOBROAD hospitals, please contact us. We strictly protect your personal information in accordance with applicable regulations.