Jazz study for adults suffering from HER2-positive biliary tract cancer

Are you Eligible to Participate in the study?

Here is a list of key Inclusion/Exclusion Criteria to participate in the study:

Key Inclusion Criteria

• Participants must have a confirmed diagnosis of HER2 positive Biliary Tract Cancer, including Gallbladder Cancer, Intrahepatic Cholangiocarcinoma, or Extrahepatic Cholangiocarcinoma that cannot be effectively treated with surgery or other local (in the body) treatments such as radiation therapy or direct tumor destruction.
• Participants may only have received up to 2 prior treatment cycles of standard therapy.
• Participants must be male or female over 18 years of age (or the legal age of adulthood per country-specific regulations).
• Females of childbearing potential must have a negative pregnancy test result.
• Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Key Exclusion Criteria

• Participants may not have received prior treatment with a HER2-targeted agent or checkpoint inhibitors. The only exception is if they have received two or fewer doses of durvalumab or pembrolizumab as part of the treatment that is allowed prior to study entry (described in the inclusion criteria).
• Participants must not use high dose systemic corticosteroids or other medications that suppress the immune system. There are some exceptions to this, please consult with your doctor about what is allowed.
• Participants must not have brain metastases.
• Participants may not have severe chronic or active infections, a history of allogeneic organ transplantation, active prior autoimmune inflammatory conditions, or interstitial lung disease or non-infectious pneumonitis.
• Participants may not have participated in another clinical trial with an investigational medicinal product within the last 3 months.
• Females who are breastfeeding are not eligible to participate.
• Participants may not have any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.