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

• Status: Recruiting
• Trial end date: 2023-03-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Daiichi Sankyo Co., Ltd.
• Treatments: Trastuzumab

Criteria

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.