Trial 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 consist of Part 1 which includes 7 cohorts of: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors; and Part 2 which includes 5 cohorts A to E of: A) any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer), B) any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer), C) HER2 IHC 2+ or 1+ endometrial cancer, D) HER2 IHC 2+ or 1+ ovarian cancer, and E) HER2 IHC 2+ or 1+ cervical cancer.
Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.
Sponsor: AstraZeneca
Participants: ALL
Start: 2020-08-18
Completion: 2027-07-30
Min Age: 18 Years
Max Age: 120 Years
Eligibility Criteria
Inclusion Criteria: * Locally advanced, unresectable, or metastatic disease based on most recent imaging. * Part 1: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. * Part 2:The respective cohorts for patient inclusion are: * Cohort A: Metastatic or advanced solid tumors that are HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included. * Cohort B: Metastatic or advanced solid tumors that are HER2 IHC 2+/ISH+ any tumor type (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included. * Cohort C: Metastatic or advanced solid endometrial cancer that is HER2 IHC 2+ or 1+. * Cohort D: Metastatic or advanced ovarian cancer that is HER2 IHC 2+ or 1+. * Cohort E: Metastatic or advanced solid cervical cancer that is HER2…
Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.