Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer

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). Olaparib is a drug that blocks an enzyme involved in many cell functions, including the repair of deoxyribonucleic acid (DNA) damage. Blocking this enzyme may help keep tumor cells from repairing their damaged DNA, causing them to die. DS-8201a is an antibody-drug conjugate. This agent has

Trial Details

NCT ID

NCT04585958

Phase

PHASE1

Sponsor

National Cancer Institute (NCI)

Status

RECRUITING

Cancer Type

High-Grade Serous Ovarian Cancer

Interventions

Biopsy Procedure
Biospecimen Collection
Computed Tomography
Echocardiography Test
Multigated Acquisition Scan
Olaparib

Locations (sample)

Phoenix, Arizona, United States|33.44838,-112.07404
Coral Gables, Florida, United States|25.72149,-80.26838
Deerfield Beach, Florida, United States|26.31841,-80.09977
Doral, Florida, United States|25.81954,-80.35533
Jacksonville, Florida, United States|30.33218,-81.65565

Key Eligibility Criteria

DOSE ESCALATION PHASE
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do…
Patients must have HER2-positive or HER2-expressing tumors determined by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory. Specifi…
Dose Escalation Module 1 and Module 2:

For full eligibility, visit ClinicalTrials.gov.

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