To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malign
This is a Phase I open, multi-center, first-in-human study evaluating JSKN016 in subjects with advanced metastatic solid tumors, divided into dose escalation and dose extension.
| Condition(s) | Advanced Malignant Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a Phase I open, multi-center, first-in-human study evaluating JSKN016 in subjects with advanced metastatic solid tumors, divided into dose escalation and dose extension. |
| Who can participate | Inclusion Criteria: * 1\. Subjects can understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. The subjects were ≥18 years old on the day of signing the informed consent, male or female; 3. Subjects with histologically and/or cytologically confirmed advanced unresectable or metastatic epithelial malignancies that have failed or are intolerable to previous standard therapies, preferentially but not limited to the following types: AGA-positive non-small cell lung cancer, HER2 IHC 0 breast cancer, etc. 4\. For AGA-positive NSCLC, the presence of at least one of the following mutations is required; EGFR, ALK, ROS1, NTRK, BRAF V600, MET exon 14, RET, KRAS G12C, or HER2; * For the enrolled subjects, the above driver gene mutations were not tested, |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
| Locations | Fuzhou, Fujian, China; Guangzhou, Guangdong, China |
| Start date | 2024-04-30 |
| NCT ID | NCT06592417 |
| Official listing | https://clinicaltrials.gov/study/NCT06592417 |