RecruitingPhase 1NCT04585958

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

A Phase I Study of DS-8201a in Combination With Olaparib in HER2-Expressing Malignancies


Sponsor

National Cancer Institute (NCI)

Enrollment

55 participants

Start Date

May 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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 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 DNA replication in the tumor cells with abundant HER2, causing them to die. Giving DS-8201a and olaparib may shrink or stabilize the cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combining two drugs — DS-8201a (trastuzumab deruxtecan, a targeted antibody-drug) and olaparib (a PARP inhibitor) — in people with HER2-expressing cancers, with a specific focus on women with platinum-resistant ovarian cancer. The goal is to find the right dose and see how effective this combination is. **You may be eligible if...** - You have a cancer that expresses HER2 (confirmed by lab testing) - For the expansion phase: you have high-grade serous ovarian cancer that progressed within 6 months of platinum chemotherapy - Your cancer is measurable or evaluable on imaging - You have had prior treatment and your cancer has stopped responding to standard therapies - Your organ function (blood counts, liver, kidneys) is within acceptable range **You may NOT be eligible if...** - Your tumor has unknown or negative HER2 status - You have had prior treatment with trastuzumab deruxtecan - You have active brain metastases - You are pregnant or breastfeeding - You have severe lung disease or active infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood and urine samples

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography Test

Undergo echocardiography

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGOlaparib

Given PO

BIOLOGICALTrastuzumab Deruxtecan

Given IV


Locations(7)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT04585958


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