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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03821233 | A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers | PHASE1 | COMPLETED | 112 | — | — | Apr 15, 2019 | Oct 8, 2024 | Jan 29, 2025 | 16 | United States, Australia +2 |
Number of participants who experienced a DLT. DLTs are events that occur following administration of any amount of ZW49 and are considered related to ZW49 per the investigator. DLTs will include only events considered related to ZW49.
Number of participants who experienced an adverse event
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology and chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Number of participants who experienced an abnormal ECG or LVEF
Number of doses reduced and number of participants who require a dose reduction
| Arm | Type | Description |
|---|---|---|
| ZW49 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ZW49 | DRUG | * Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC * Expansion: MTD or RD identified in the dose-escalation part of the study |
Inclusion Criteria: * Pathologically-confirmed diagnosis of breast cancer, gastroesophageal adenocarcinoma (GEA), or other HER2-expressing cancer with evidence of locally advanced (unresectable) and/or metastatic disease. * Dose-escalation (Cohort 1): HER2-high advanced solid tumors * Expansio...