Colorectal Cancer Metastatic
Conditions
Brief summary
To evaluate the safety and efficacy of SHR-A1904 in the advanced colorectal cancer after failure of standard therapy
Detailed description
This is a single-center, open-label, exploratory clinical trial designed to investigate the efficacy and safety of SHR-A1904 for the treatment of metastatic colorectal cancer.
Interventions
DRUGSHR-A1904
SHR-A1904
Sponsors
Peking University Cancer Hospital & Institute
Beijing GoBroad Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (Open Label)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years, male or female. 2. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma. 3. Failure of at least second-line standard systemic therapy, and must have received oxaliplatin, irinotecan, and fluoropyrimidine-based chemotherapy. Subjects who have received all three classes of chemotherapeutic agents in first-line therapy may be enrolled after first-line treatment failure. For subjects with dMMR/MSI-H tumors, prior anti-PD-1/PD-L1 antibody therapy must have failed. 4. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1. 6. Life expectancy ≥ 3 months. 7. Adequate major organ and bone marrow function before first dose of study drug, meeting the following criteria: 1. Hematology (without transfusion, G-CSF or other medical support within 14 days before study drug administration): Hemoglobin ≥ 90 g/L; Platelets (PLT) ≥ 100×10\^9/L; White blood cells (WBC) ≥ 3.5×10\^9/L; Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L. 2. Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (in case of liver metastases, AST/ALT ≤ 5×ULN is permitted). 3. Renal function: Creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula). 4. Coagulation: International normalized ratio (INR) ≤ 1.5×ULN (or INR 2-3 for patients on stable long-term warfarin therapy), and activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤ 1.5×ULN. 8. Male patients and female patients of childbearing potential must agree to use adequate and effective contraception during the study and for 12 months after the last dose. Female patients must not be breastfeeding and must have a negative serum pregnancy test (β-hCG) within 7 days before the first dose. 9. Willing to voluntarily participate in this study, sign informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
1. Known history of hypersensitivity to any component of the investigational product. 2. Received systemic anti-tumor therapy within 4 weeks before the start of study treatment. If prior anti-tumor therapy was small molecule targeted therapy, the interval between the end of that treatment and the first study treatment should be no less than 5 half-lives of the drug or 7 days, whichever is longer. If prior anti-tumor Chinese patent medicine was received, an interval of no less than 2 weeks between the end of that treatment and the first study treatment is allowed. 3. Toxicities and/or complications from prior interventions have not recovered to NCI-CTCAE grade ≤1 or to the level specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment related adverse event [Safety and Tolerability] | From the initiation of the first dose to 90 days after the last dose | To identify the incidence of adverse events (AEs) and severe adverse events (SAEs) in clinical trial |
| Objective response rate (ORR) | From enrollment to the end of treatment at 6 weeks | To evaluate the efficacy of anti-tumor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | From enrollment to the end of treatment at 6 weeks | To evaluate the efficacy of anti-tumor |
| Disease control rate (DCR) | From enrollment to the end of treatment at 6 weeks | To evaluate the efficacy of anti-tumor |
| Progression-free survival (PFS) | From enrollment to the end of treatment at 12 weeks | To evaluate the efficacy of anti-tumor |
| Overall survival (OS) | From enrollment to the end of treatment at 12 months | To evaluate the efficacy of anti-tumor |
Countries
China
Contacts
CONTACTJian Li
Outcome results
None listed