Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZW251 · 1 trial · 3 indications
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW251
Number of participants who experienced AEs, adverse events of special interest, or serious adverse events
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0
Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
| Arm | Type | Description |
|---|---|---|
| ZW251 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ZW251 | DRUG | Administered intravenously |
Inclusion Criteria: * Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and/or metastatic disease. Noninvasive methods may be used to confirm diagnosis * Pathologically or cytologically confirmed diagnosis of s...
ZW251 is an investigational small molecule developed by Zymeworks Inc. for the treatment of advanced solid tumors, including hepatocellular carcinoma. It is currently in Phase 1 clinical development and has not been approved by any regulatory agency. The drug is designed to target GPC3, a protein expressed in certain cancers.
ZW251 is being studied for use in hepatocellular carcinoma, the most common form of liver cancer. It is also being evaluated in squamous cell non-small cell lung cancer and germ cell tumors. As an investigational therapy, ZW251 has not been approved for any indication and is available only through clinical trials.
ZW251 targets GPC3, a cell surface protein that is overexpressed in hepatocellular carcinoma and some other solid tumors. By binding to GPC3, ZW251 aims to deliver a therapeutic effect to cancer cells. This targeted approach is intended to focus the drug's activity on tumor cells while limiting effects on normal tissues.
ZW251 is being developed by Zymeworks Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ZYME. Zymeworks is responsible for the clinical development and potential commercialization of ZW251. The company's pipeline includes other oncology candidates as well.
ZW251 is in Phase 1 clinical development. The ongoing trial is designed to evaluate the safety, tolerability, and preliminary activity of ZW251 in participants with advanced solid tumors. As a Phase 1 investigational drug, ZW251 has not received FDA approval or any other regulatory approval.
ZW251 is being evaluated in a Phase 1 clinical trial, NCT07164313, titled A Study of ZW251 in Participants With Advanced Solid Tumors. The trial is currently recruiting and plans to enroll approximately 140 participants across the United States, Ireland, Japan, Portugal, Spain, and Taiwan. It includes patients with hepatocellular carcinoma, squamous cell non-small cell lung cancer, and germ cell tumors.