A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

  • STATUS
    Recruiting
  • End date
    Jan 19, 2023
  • participants needed
    100
  • sponsor
    Zymeworks Inc.
Updated on 22 August 2021

Summary

This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

Details
Condition HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers, HER2-amplified Biliary Tract Cancers
Treatment ZW25 (Zanidatamab), In situ hybridization (ISH)-based companion diagnostic assay, Immunohistochemistry (IHC)-based companion diagnostic assay
Clinical Study IdentifierNCT04466891
SponsorZymeworks Inc.
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically- or cytologically-confirmed BTC, including ICC, ECC or GBC
Locally advanced or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies
Received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for advanced disease, and experienced disease progression after or developed intolerance to the most recent prior therapy. For subjects who received gemcitabine in prior adjuvant or neoadjuvant treatment, if progression occurred < 6 months from the latter of primary surgical resection or completion of gemcitabine-containing adjuvant therapy, they will be considered as having received 1 prior line of therapy for advanced disease
Subjects must test positive for HER2 amplification by ISH-assay at a central laboratory on a new biopsy or archival tissue. Note that fine needle aspirates (FNAs; cytology samples) and biopsies from sites of bone metastases are not acceptable. Testing may occur at any time after diagnosis of advanced or metastatic disease and before study enrollment
Male or female, 18 years of age (or the legal age of adulthood per country-specific regulations)
Eastern Cooperative Oncology Group (ECOG) performance status 1
Adequate organ function
Adequate cardiac function, as defined by left ventricular ejection fraction 50%

Exclusion Criteria

Received systemic anti-cancer therapy within 3 weeks of the first dose of ZW25. Received radiotherapy within 2 weeks of the first dose of ZW25
Prior treatment with HER2-targeted agents
Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening)
Known leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline MRI, but is not suspected clinically by the investigator, the subject must be free of neurological symptoms of LMD
Concurrent uncontrolled or active hepatobiliary disorders or untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, unresolved biliary obstruction, infected biloma or abscess. Any complications must be resolved more than 2 weeks prior to the first dose of ZW25
Prior or concurrent malignancy whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen
Active hepatitis
Infection with human immunodeficiency virus (HIV)-1 or HIV-2
QTc Fridericia (QTcF) > 470 ms
History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease
Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note