A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and
 safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing
 tumors.

 This study will enroll 7 tumor-specific cohorts: urothelial bladder cancer, biliary tract
 cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare
 tumors.

 Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a
 favorable risk benefit profile in selected HER2-expressing solid 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:

 -  Uncontrolled intercurrent illness

 -  History of non-infectious pneumonitis/ILD, 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.