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The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of metastatic colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Two phase study of Recombinant full human Anti-epidermal growth factor receptor(EGFR) Monoclonal Antibody: First phase: seven escalating single-dose groups : 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 mg/kg Second phase: multiple-dose groups 0.5, 1.0, 2.0, 3.0 mg/kg: weekly once for 4 doses; 5.0, 6.0 mg/kg: every two weeks for 2 doses; 4.0 mg/kg: weekly or every two weeks depends on the results of previous dose groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant full human Anti-EGFR Monoclonal Antibody | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with SCT200-related adverse events | up to 105 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the plasma concentration versus time curve (AUC) of SCT200 | prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression (TTP) of SCT200 | up to 105 days |
Inclusion Criteria:
aged from 18 to 70 years;
having histologically confirmed metastatic colorectal cancer;
having experienced previous treatment failures including fluoropyrimidine, irinotecan and oxaliplatine chemotherapy regiment;
having determined wild-type KRAS tumor;
having to have measurable or nonmeasurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected survival of at least ≥3 months;
adequate hematological, renal and liver functions:
no other malignancies only if they had following malignancies , which were not required to treat or who had curative resection: cervical carcinoma in situ, the skin basal carcinoma or squamous cell carcinoma, bladder epithelial tumors, or only they had some malignancies requirement only surgical therapy and disease free survival≥5 years;
no serious nonmalignant diseases including hypertension, diabetes mellitus, coronary artery disease, and mental disorder.
not pregnant; or not lactating; or accepted birth control methods during the study;
signed an informed consent form which was approved by the institutional review board of the respective medical center .
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36307775 | Derived | Zhang W, Han X, Yang L, Song Y, Xie L, Gai W, Wang Y, Shi Y. Safety, pharmacokinetics and efficacy of SCT200, an anti-EGFR monoclonal antibody in patients with wild-type KRAS/NRAS/BRAF metastatic colorectal cancer: a phase I dose-escalation and dose-expansion study. BMC Cancer. 2022 Oct 28;22(1):1104. doi: 10.1186/s12885-022-10147-9. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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