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NCT04482309 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
A Phase 2 study of Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer and Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 468
- Enrollment target
- 20
- Study locations
NCT04482309: Recruiting Phase 2 study of Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer and Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer, sponsored by AstraZeneca.
NCT04482309 is a Phase 2 study of Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer and Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 468 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (252% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04482309, a Phase 2 study of Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer and Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 468 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
Conditions Studied
Interventions
- DRUG Trastuzumab deruxtecan
Study Locations (20)
California
- Research Site - Burbank
- Research Site - Duarte
- Research Site - Fullerton
- Research Site - La Jolla
- Research Site - Los Angeles
- Research Site - Santa Rosa
New York
- Research Site - Harrison
- Research Site - New York
- Research Site - New York
- Research Site - Rochester
Illinois
- Research Site - Chicago
Indiana
- Research Site - Muncie
Massachusetts
- Research Site - Boston
Michigan
- Research Site - Detroit
Missouri
- Research Site - St Louis
New Jersey
- Research Site - Middletown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 2 |
What NCT04482309 shows while recruiting
NCT04482309 is an interventional study that assigns participants to a tested intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (252% higher).
The record links to 2 conditions, with Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab deruxtecan is the first listed.
NCT04482309 names 20 study sites across 12 states, led by California, New York, Illinois.
Frequently Asked Questions
What is clinical trial NCT04482309 about?
NCT04482309 is a clinical study titled "A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors". 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...
What is the current status of trial NCT04482309?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 468 participants. The study started on 2020-08-18. Estimated completion is 2027-07-30.
What conditions does trial NCT04482309 study?
This clinical trial studies the following conditions: Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer.
What interventions are being tested in trial NCT04482309?
The interventions under investigation include: Trastuzumab deruxtecan (DRUG).
Who is sponsoring clinical trial NCT04482309?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04482309 being conducted?
This trial has 20 study locations across California, Illinois, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04482309's enrollment target sits among peer trials
468 80th of 2000 higher than 1,921 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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