A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
| Condition(s) | Advanced Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors. |
| Who can participate | Inclusion Criteria: 1. Voluntary participation and written informed consent. 2. 18-75 years older, no gender limitation. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 4. With a life expectancy ≥ 3 months. 5. Pathologically diagnosed advanced solid tumor. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. Adequate bone marrow reserve and organ function. 9. Contraception is required during the trial. Exclusion Criteria: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. Uncontrollable tumor-related pain. 3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 4. Received systemic antitumor therapy before the first dose. 5. Trea |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Locations | Chengdu, Sichuan, China |
| Start date | 2024-11-13 |
| NCT ID | NCT06618651 |
| Official listing | https://clinicaltrials.gov/study/NCT06618651 |