OncoMatch/Clinical Trials/NCT04585958
Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer
Is NCT04585958 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Trastuzumab Deruxtecan and Olaparib for metastatic malignant solid neoplasm.
Treatment: Olaparib · Trastuzumab Deruxtecan — This phase I trial identifies the side effects and best dose of DS-8201a and olaparib in treating patients with HER2-expressing cancers that have spread to other places in the body or cannot be removed by surgery or ovarian cancer that remains despite treatment with a platinum treatment (platinum resistant). DS-8201a is an antibody-drug conjugate. This agent has two components: an antibody component and a chemotherapy component. The antibody component is attached to the chemotherapy molecules. Upon administration of DS-8201a, the antibody targets and binds to tumor cells that have abundant HER2 (human-epidermal growth factor receptor 2), which is a protein on the surface of some tumor cells. The chemotherapy then enters the cells and blocks deoxyribonucleic acid (DNA) replication in the tumor cells with abundant HER2, causing them to die. Olaparib is a drug that blocks an enzyme involved in many cell functions, including the repair of DNA damage. Blocking this enzyme may help keep tumor cells from repairing their damaged DNA, causing them to die. Giving DS-8201a and olaparib may shrink or stabilize the cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) expression (IHC 1+ or higher)
HER2 1-3+ expression by IHC OR HER2 amplification by next generation sequencing panel (NGS) or in situ hybridization (ISH)
Required: HER2 (ERBB2) amplification
HER2 amplification by next generation sequencing panel (NGS) or in situ hybridization (ISH)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cytotoxic chemotherapy
Patients must have had at least one prior line of cytotoxic chemotherapy
Lab requirements
Blood counts
Hemoglobin >= 10.0 g/dL; Absolute neutrophil count >= 1,000/mcL; Platelets >= 100,000/mcL
Kidney function
Creatinine <= 1.5 x institutional ULN OR GFR >= 51 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2
Liver function
Total bilirubin <= 1.5 x institutional ULN (< 3 x ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline); AST/ALT <= 3 x institutional ULN
Cardiac function
Left ventricular ejection fraction (LVEF) >= 50% by ECHO or MUGA; NYHA class better than 2B; QTc <= 470 ms (females) or <= 450 ms (males)
Hemoglobin >= 10.0 g/dL ... Absolute neutrophil count >= 1,000/mcL ... Platelets >= 100,000/mcL ... Total bilirubin <= 1.5 x institutional ULN (< 3 x ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline) ... AST/ALT <= 3 x institutional ULN ... Creatinine <= 1.5 x institutional ULN OR GFR >= 51 mL/min/1.73 m^2 ... LVEF >= 50% ... NYHA class better than 2B ... QTc <= 470 ms (females) or <= 450 ms (males)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, Florida
- UM Sylvester Comprehensive Cancer Center at Doral · Doral, Florida
- Mayo Clinic in Florida · Jacksonville, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04585958 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received cytotoxic chemotherapy.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages