Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05055232 | A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer | PHASE1 | COMPLETED | 114 | — | — | Mar 12, 2019 | Aug 15, 2023 | Jul 24, 2025 | 1 | China |
Characterization of the safety and tolerability of XZP-3621 as determined by changes in laboratory values and electrocardiograms
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of XZP-3621 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 4 weeks.
The MTD is determined by the number of the participants in cohort who suffer a dose-limiting toxicity (DLT). The MTD is defined as the former dose at which more than one third of the participants develop a DLT. If no DLTs are observed, the MTD is not reached.
| Arm | Type | Description |
|---|---|---|
| XZP-3621 | EXPERIMENTAL | The first part is a dose-escalation design in patients with ALK/ROS1-positive solid tumor. The second part is an expansion in non-small cell lung Cancer (NSCLC) characterized by abnormalities in ALK expression. |
| Name | Type | Description |
|---|---|---|
| XZP-3621 | DRUG | tablets, dosage ranged from 50 mg to 600 mg, quaque die（QD）with the meal. |
Inclusion Criteria: 1. Male or female subjects aged 18-75 years (including 18 and 75 years); 2. Stage IV NSCLC or Stage IIIB and IIIC NSCLC that cannot be treated with radical radiotherapy(IASLC); Dose escalation: ALK rearrangement or ROS1 rearrangement positive, the test specimen and method is not...