Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial
Public ClinicalTrials.gov record NCT04704661. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1/1B Study of DS-8201a in Combination With ATR Inhibition (AZD6738) in Advanced Solid Tumors With HER2 Expression (DASH Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The dose escalation phase of this trial identifies the safety, side effects and best dose of ceralasertib (AZD6738) when given in combination with trastuzumab deruxtecan (DS-8201a) in treating patients with solid tumors that have a change (mutation) in the HER2 gene or protein and have spread to other places in the body (advanced). The dose expansion phase (phase Ib) of this trial compares how colorectal and gastroesophageal cancers with HER2 mutation respond to treatment with a combination of ceralasertib and trastuzumab deruxtecan versus trastuzumab deruxtecan alone. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Ceralasertib and trastuzumab deruxtecan may be safe, tolerable and effective in treating patients with advanced solid tumors expressing the HER2 protein or gene.
Study identification
- NCT ID
- NCT04704661
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 51 participants
Conditions and interventions
Conditions
- Advanced Breast Carcinoma
- Advanced Colon Carcinoma
- Advanced Colorectal Carcinoma
- Advanced Endometrial Carcinoma
- Advanced Gastric Carcinoma
- Advanced Gastroesophageal Junction Adenocarcinoma
- Advanced Malignant Solid Neoplasm
- Advanced Salivary Gland Carcinoma
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IV Gastric Cancer AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- HER2-Positive Breast Carcinoma
- Malignant Hepatobiliary Neoplasm
- Metastatic Breast Carcinoma
- Metastatic Colon Carcinoma
- Metastatic Colorectal Carcinoma
- Metastatic Endometrial Carcinoma
- Metastatic Gastric Carcinoma
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Metastatic Malignant Solid Neoplasm
- Metastatic Salivary Gland Carcinoma
- Stage III Colon Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Stage III Major Salivary Gland Cancer AJCC v8
- Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
- Stage IV Colon Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Major Salivary Gland Cancer AJCC v8
- Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
- Unresectable Breast Carcinoma
- Unresectable Colon Carcinoma
- Unresectable Colorectal Carcinoma
- Unresectable Endometrial Carcinoma
- Unresectable Gastric Carcinoma
- Unresectable Gastroesophageal Junction Adenocarcinoma
- Unresectable Malignant Solid Neoplasm
- Unresectable Salivary Gland Carcinoma
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Ceralasertib Drug
- Computed Tomography Procedure
- Echocardiography Test Procedure
- Multigated Acquisition Scan Procedure
- Positron Emission Tomography Procedure
- Trastuzumab Deruxtecan Biological
Procedure · Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 8, 2021
- Primary completion
- Mar 30, 2027
- Completion
- Mar 30, 2027
- Last update posted
- Aug 26, 2026
2021 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | — |
| Memorial Hospital East | Shiloh | Illinois | 62269 | — |
| National Cancer Institute Developmental Therapeutics Clinic | Bethesda | Maryland | 20892 | — |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| University of Texas at Austin | Austin | Texas | 78712 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04704661, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04704661 live on ClinicalTrials.gov.