OncoMatch/Clinical Trials/NCT04704661
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
Is NCT04704661 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Trastuzumab Deruxtecan and Ceralasertib for advanced breast carcinoma.
Treatment: Ceralasertib · Trastuzumab Deruxtecan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Colorectal Cancer
Endometrial Cancer
Gastric Cancer
Esophageal Carcinoma
Tumor Agnostic
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) 1+ (IHC 1+)
HER2 expression (1-3+) by IHC locally and confirmed centrally OR HER2 expression (1-3+) by IHC tested centrally
Required: HER2 (ERBB2) 2+ (IHC 2+)
HER2 expression (1-3+) by IHC locally and confirmed centrally OR HER2 expression (1-3+) by IHC tested centrally
Required: HER2 (ERBB2) 3+ (IHC 3+)
HER2 expression (1-3+) by IHC locally and confirmed centrally OR HER2 expression (1-3+) by IHC tested centrally
Required: HER2 (ERBB2) amplification
HER2 amplification based on fluorescence in situ hybridization (FISH) or next generation sequencing
Disease stage
Required: Stage IV
Metastatic disease required
Must have unresectable, advanced/metastatic disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic chemotherapy — locally advanced or metastatic
Must have received at least one line of systemic chemotherapy for either locally advanced or metastatic disease and should have either progressed on this therapy or been intolerant to this therapy
Cannot have received: HER2-targeted therapy (DS-8201a)
Exception: For patients where DS8201a is approved as standard of care, prior treatment with DS8201a is not allowed
For patients where DS8201a is approved as standard of care, prior treatment with DS8201a is not allowed
Cannot have received: ATR inhibitor
Any previous treatment with an ATR inhibitor
Lab requirements
Blood counts
Platelets >= 100,000/mcL; Hemoglobin >= 9.0 g/dL; Absolute neutrophil count >= 1,500/mcL; Leukocytes >= 3,000/mcL (within 14 days before enrollment)
Kidney function
Creatinine clearance > 45/mL/min (using the Cockcroft-Gault equation) (within 14 days before enrollment)
Liver function
AST/ALT <= 5 x ULN (within 14 days before enrollment); Total bilirubin <= 1.5 x ULN if no liver metastases or < 3 x ULN with Gilbert's Syndrome or liver metastases at baseline (within 14 days before enrollment)
Cardiac function
LVEF >= 50% within 28 days before enrollment (study drug treatment) by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Platelets >= 100,000/mcL ... Hemoglobin >= 9.0 g/dL ... Absolute neutrophil count >= 1,500/mcL ... Creatinine clearance > 45/mL/min ... AST/ALT <= 5 x ULN ... Total bilirubin <= 1.5 x ULN if no liver metastases or < 3 x ULN with Gilbert's Syndrome or liver metastases at baseline ... LVEF >= 50% within 28 days before enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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