A Phase IIB Study of ZW25 in People with Advanced HER2-Positive Biliary Tract Cancers

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Full Title

A Phase 2b, Open-Label, Single-Arm Study of ZW25 Monotherapy in Subjects with Advanced or Metastatic HER2-amplified Biliary Tract Cancers

Purpose

The goal of this study is to assess the safety and effectiveness of the investigational drug ZW25 in patients with advanced or metastatic biliary tract cancers (such as cholangiocarcinoma and gallbladder cancer) that produce the HER2 protein. ZW25 is designed to fight cancer by targeting HER2. ZW25 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced or metastatic intra-hepatic (in the liver) cholangiocarcinoma, extra-hepatic (outside the liver) cholangiocarcinoma, or gallbladder cancer that produces the HER2 protein.
  • Patients’ tumors must persist despite prior therapy.
  • At least 4 weeks must pass since major surgery, 3 weeks since completion of chemotherapy, and 2 weeks since radiation therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. James Harding at 646-888-4314.

Protocol

20-453

Phase

II

Investigator

Co-Investigators