A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

Inclusion Criteria:

Locally advanced, unresectable, or metastatic disease based on most recent imaging.

The respective cohorts for patient inclusion are:

Cohort 1: Biliary tract cancer
Cohort 2: Bladder cancer
Cohort 3: Cervical cancer
Cohort 4: Endometrial cancer
Cohort 5: Epithelial ovarian cancer
Cohort 6: Pancreatic cancer
Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.
Progressed following prior treatment or who have no satisfactory alternative treatment option.
Prior HER2 targeting therapy is permitted.
HER2 expression for eligibility may be based on local or central assessment.
Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
Has protocol- defined adequate organ function including cardiac, renal and hepatic function.

Exclusion Criteria:

History of non-infectious pneumonitis/ILD that required steroids, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
Lung-specific intercurrent clinically significant severe illnesses
Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART
Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.
Medical conditions that may interfere with the subject's participation in the study.