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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate (ORR)

Primary Outcome 1 - Timeframe: An average of approximately 12 months

CONDITION

• Bladder Cancer
• Biliary Tract Cancer
• Cervical Cancer
• Endometrial Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Rare Tumors

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION