Clinical Trial: NCT05055232
A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Xuanzhu Biopharmaceutical Co., Ltd. |
| Information Provided By: | Xuanzhu Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2025-07-24 |
Study Overview
Brief Summary
This is a multicenter, open-label, dose escalation, and expansion human clinical study to observe the safety, tolerability, pharmacokinetics, and pharmacodynamics of XZP-3621 in single and multiple oral administrations in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement, and to initially explore the efficacy of XZP-3621.The study was divided into two parts: dose escalation and dose expansion.
Official Title
Conditions
Intervention / Treatment
- Drug: XZP-3621
Other Study ID Numbers
- XZP-3621-1001
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Xuanzhu Biopharmaceutical Co., Ltd. |
| Information Provided By: | Xuanzhu Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2025-07-24 |
Study Overview
Brief Summary
This is a multicenter, open-label, dose escalation, and expansion human clinical study to observe the safety, tolerability, pharmacokinetics, and pharmacodynamics of XZP-3621 in single and multiple oral administrations in advanced NSCLC subjects with ALK rearrangement or ROS1 rearrangement, and to initially explore the efficacy of XZP-3621.The study was divided into two parts: dose escalation and dose expansion.
Official Title
Conditions
Intervention / Treatment
- Drug: XZP-3621
Other Study ID Numbers
- XZP-3621-1001