This study is an open label, multicenter Phase II clinical trial aimed at evaluating the safety and efficacy of JS207 with or without JS015 in combination with chemotherapy (XELOX) as a first-line treatment for advanced colorectal cancer with MSS/pMMR. The study was divided into two cohorts: Cohort 1 was JS207 combined with XELOX, and Cohort 2 was JS207 combined with JS015 and XELOX.
Subjects aged 18 to 75 (inclusive) at the time of signing the consent form, both male and female
Colorectal adenocarcinoma or rectal adenocarcinoma with histological or cytological Qualification, according to the 8th edition of the AJCC colorectal cancer TNM staging stage IV, MSS/pMMR (a qualified report of MSS or pMMR detected by a local laboratory must be provided), and no previous systemic anti-tumor therapy for advanced disease; for patients who have received neoadjuvant or adjuvant systemic therapy, the last treatment to relapse or progression takes more than 12 months
ECOG score is 0 or 1
Estimated survival ≥ 12 weeks
Previously received PD-1 or programmed cell death ligand 1 (PD-L1) inhibitor therapy; or previously received DKK1 inhibitor therapy (only for cohort 2 subjects)
Received the following medications or treatments before the first dose Within 28 days before the first dose, major surgery and radiotherapy (palliative radiotherapy for local bone/brain lesions, allowed to be completed within 14 days before the first dose) were performed. Within 7 days before the start of the study, coarse needle aspiration biopsy or other minor surgery was performed, excluding the placement of vascular infusion devices.
The toxicity of previous anti-tumor treatment has not been restored to the level specified in CTCAE v5.0 or the level specified in the inclusion/exclusion criteria, except for the following cases: the relevant toxicity that has been judged by the investigator to be well controlled and does not affect the safety and compliance of the patient with the study drug can be screened after qualification with the sponsor
Digestive tract perforation, fistula, abdominal abscess, and digestive system ulcerative diseases or a history thereof within 6 months prior to the first medication (the investigator may consider inclusion if the ulcer condition is stable)
Single group
JS207
Biological/VaccineJS207 will be administered every 3 weeks for a treatment cycle of 21 days
JS015
Biological/VaccineJS015 will be administered every 3 weeks for a treatment cycle of 21 days
Capecitabine
DrugCapecitabine of 1000mg/m2 will be administered orally twice daily from day 1 to 14 every 21 day cycle
Oxaliplatin
DrugOxaliplatin of 130mg/m2 will be administered intravenously (IV) on day 1 every 21 day cycle
Dose-limiting toxicity （DLT)
Incidence and severity of DLT
Adverse event（AE）
Adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance
RP3D
Recommended dose for phase II trial
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
Progression free survival(PFS)
The time from first dose to Disease progression or death
Overall survival (OS)
The time from first dose to death from any cause
Immunogenicity
Incidence of Anti-Drug Antibody (ADA)
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