Advanced Colorectal Cancer
Conditions
Brief summary
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.
Interventions
DRUGOxaliplatin
Oxaliplatin of 130mg/m2 will be administered intravenously (IV) on day 1 every 21 day cycle
BIOLOGICALJS207
JS207 will be administered every 3 weeks for a treatment cycle of 21 days
BIOLOGICALJS015
JS015 will be administered every 3 weeks for a treatment cycle of 21 days
DRUGCapecitabine
Capecitabine of 1000mg/m2 will be administered orally twice daily from day 1 to 14 every 21 day cycle
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 18 to 75 (inclusive) at the time of signing the consent form, both male and female 2. 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 3. ECOG score is 0 or 1 4. Estimated survival ≥ 12 weeks 5. According to the RECIST v1.1 evaluation standard, there is at least one measurable lesion 6. Good organ function 7. Female or male subjects with fertility must agree to have no family planning during the study period and voluntarily use effective contraception with significant others within 6 months after the end of the last medication. Female subjects with fertility (WOCBP) must have a negative serum pregnancy test within 7 days before the first medication and be non-lactating (see section 10.3 for specific contraceptive measures and WOCBP definitions) 8. The patient participated voluntarily, gave full informed consent, signed a written ICF, and had good compliance
Exclusion criteria
1. 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) 2. 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. Within 14 days before the first medication, antiplatelet therapy such as aspirin (≥ 325 mg/day), clopidogrel (≥ 75 mg/day), or anticoagulant therapy for therapeutic purposes have been used. Patients who have received systematic treatment with corticosteroids (\> 10 mg prednisone or equivalent dose per day) or other immunosuppressants for more than 1 week before the first dose are allowed to use inhaled or topical steroids or ≤ 10 mg/day systemic prednisone and equivalent doses of similar drugs for treatment. D) Have received any live vaccine or attenuated live vaccine within 28 days before the first dose, or expect to receive live vaccine or attenuated live vaccine during the study period (limited to patients in combination therapy studies); 3. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity （DLT) | 2 Years | Incidence and severity of DLT |
| Adverse event（AE） | 2 Years | Adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance |
| RP3D | 2 Years | Recommended dose for phase II trial |
| Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) | 2 years | Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 2 years | The time from first dose to death from any cause |
| Immunogenicity | 2 years | Incidence of Anti-Drug Antibody (ADA) |
| Progression free survival(PFS) | 2 years | The time from first dose to Disease progression or death |
Countries
China
Contacts
Primary ContactChengbo Jia, Master
Outcome results
None listed