Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZW49 · 1 trial · 1 indication
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...
ZW49 is an investigational small molecule being studied for the treatment of HER2-expressing cancers. It is designed to target cancer cells that express the HER2 protein, which is found on the surface of certain tumors. The drug is currently in clinical development for this oncology indication.
ZW49 targets HER2, a protein that is overexpressed in certain types of cancer. By binding to HER2, ZW49 aims to deliver a therapeutic effect specifically to HER2-expressing tumor cells. This targeted approach is being evaluated in patients with HER2-positive cancers.
ZW49 is being developed by Zymeworks Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ZYME. Zymeworks is responsible for the clinical development and manufacturing of ZW49 for the treatment of HER2-expressing cancers.
ZW49 is in Phase 1 clinical development. It has completed a Phase 1 dose-finding study in patients with HER2-positive cancers. The drug is still investigational and has not been approved by regulatory authorities for commercial use.
ZW49 has been studied in one clinical trial, identified as NCT03821233, titled "A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers." This Phase 1 study enrolled 112 participants with HER2-expressing cancers and was conducted in the United States, Australia, Canada, and South Korea. The trial has been completed.
ZW49 is a distinct investigational drug developed by Zymeworks Inc. It is not known to be the same as any other approved or marketed medication. Its unique mechanism of targeting HER2-expressing cancers is being evaluated in clinical trials, but it has no established alternative names.