A Single-arm, Open-label Study of GK01 in Combination With or Without Chemotherapy for the
This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.
| Condition(s) | Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors. |
| Who can participate | * Ability to understand and sign a written informed consent document. * At the date of signing ICF, 18 \~70 years old, male or female. * Patients with solid tumors confirmed by histopathology (including but not limited to pancreatic cancer, cholangiocarcinoma, gastric cancer, etc.) who are judged by investigator to be capable of undergoing radical total resection of the primary tumor for the purpose of cure. * No treatment for the primary tumor was received before surgical resection (no induction therapy or recurrent disease). * The expected survival time is more than 12 weeks;. * ECOG 0-1 points. Exclusion Criteria: * Inoperable or metastatic (Stage IV) solid tumors. * Central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic spinal cord compression; or a history of C |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Locations | Tianjin, China |
| Start date | 2025-10-16 |
| NCT ID | NCT07351903 |
| Official listing | https://clinicaltrials.gov/study/NCT07351903 |