A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181
An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
| Condition(s) | Advanced Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy. |
| Who can participate | Inclusion Criteria: 1. Subjects who voluntarily signed a written informed consent form before the start of the study; 2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy . 3. Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1; 4. At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) \[Patients with alopecia (any grade), hyper |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Ganzhou Hemay Pharmaceutical Co., Ltd |
| Locations | Xinxiang, Henan, China |
| Start date | 2025-12-03 |
| NCT ID | NCT07446816 |
| Official listing | https://clinicaltrials.gov/study/NCT07446816 |