Brief 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 bladdera hollow, muscular sac in the pelvis that stores urine cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs, 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 colorectalrelating to the colon or rectum in the large bowel/intestine 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 riskthe possibility that something bad will happen benefit profile in selected HER2-expressing solid tumors.
Intervention / Treatment
- Drug: Trastuzumab deruxtecan
Inclusion Criteria:
- Locally advancedat a late stage, far along, unresectable, or metastatic disease based on most recent imagingtests that create detailed images of areas inside the body.
- 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 IHC 2+ or 1+.
- Progressed following prior treatment or who have no satisfactory alternative treatment option.
- Prior HER2 targeting therapy is permitted.
- HER2 expression scored using current ASCO/CAP guidelines for scoring HER2 for gastric cancer.
- Part 1: IHC 3+ or IHC 2+ by local or central assessment
- Part 2: IHC and ISH results by central assessment as pre-defined for each cohort
- 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.