A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
Trastuzumab deruxtecan: Trastuzumab deruxtecan by intravenous infusion
Study 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.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) — An average of approximately 6 months
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
Trial sites (89)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Duarte | California | |
| Research Site | Santa Rosa | California | |
| Research Site | Chicago | Illinois | |
| Research Site | Muncie | Indiana | |
| Research Site | Boston | Massachusetts | |
| Research Site | Middletown | New Jersey | |
| Research Site | Harrison | New York | |
| Research Site | New York | New York | |
| Research Site | New York | New York | |
| Research Site | Durham | North Carolina | |
| Research Site | Houston | Texas | |
| Research Site | Seattle | Washington | |
| Research Site | Auchenflower | Australia | |
| Research Site | Blacktown | Australia | |
| Research Site | Camperdown | Australia | |
| Research Site | Heidelberg | Australia | |
| Research Site | Melbourne | Australia | |
| Research Site | Nedlands | Australia | |
| Research Site | Brussels | Belgium | |
| Research Site | Leuven | Belgium | |
| Research Site | Liège | Belgium | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | Vitória | Brazil | |
| Research Site | Kelowna | British Columbia | |
| Research Site | Ottawa | Ontario | |
| Research Site | Québec | Quebec | |
| Research Site | Montreal | Canada | |
| Research Site | Brno | Czechia | |
| Research Site | Hradec Králové | Czechia | |
| Research Site | Olomouc | Czechia | |
| Research Site | Prague | Czechia | |
| Research Site | Prague | Czechia | |
| Research Site | Delhi | India | |
| Research Site | Gurgaon | India | |
| Research Site | Kolkata | India | |
| Research Site | Mumbai | India | |
| Research Site | Milan | Italy | |
| Research Site | Milan | Italy | |
| Research Site | Naples | Italy |
+ 49 more sites — see the full list on the official registry below.
On this site
📄 Enhertu (trastuzumab deruxtecan) drug profile →More AstraZeneca trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04482309 on ClinicalTrials.gov ↗ ← All trials in Spain