Cholangiocarcinoma (Bile Duct Cancer) Clinical Trials

• Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.

• Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is \> 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.

• Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.

• Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.

• Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)

• WHO/ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.

• Adequate organ and bone marrow function within 14 days before randomization.

• Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.

• Minimum life expectancy of 12 weeks.