New drug cocktail targets Hard-to-Treat HER2 cancers

NCT ID NCT04585958

Recruiting now Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 4 times

Summary

This early-phase trial tests a combination of two drugs—DS-8201a and olaparib—in people with advanced HER2-expressing cancers that have spread or cannot be removed. DS-8201a delivers chemotherapy directly to HER2-positive tumor cells, while olaparib blocks DNA repair in cancer cells. The study aims to find the safest dose and see if the combo can shrink tumors. About 55 adults with metastatic solid tumors or platinum-resistant ovarian cancer will take part.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: DS-8201a (a targeted chemotherapy) and olaparib (a DNA repair blocker)
What this could lead to: If it works, this combination could shrink or stabilize advanced HER2-expressing cancers that have not responded to other treatments.
What could go wrong: This is an early Phase I trial with only 55 participants, so the main goal is safety and dosing—not yet proof of effectiveness. Side effects from combining two strong drugs are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cancer metastatic malignant neoplasm Neoplasm Metastasis ovarian serous adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

METASTATIC MALIGNANT SOLID NEOPLASM PLATINUM-RESISTANT OVARIAN HIGH GRADE SEROUS ADENOCARCINOMA UNRESECTABLE MALIGNANT SOLID NEOPLASM

Contacts and locations

Locations

Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Emory University Hospital Midtown
RECRUITING

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
RECRUITING

Atlanta, Georgia, 30322, United States
Mayo Clinic Hospital in Arizona
ACTIVE_NOT_RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic in Florida
RECRUITING

Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Doral
RECRUITING

Doral, Florida, 33166, United States
UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITING

Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITING

Plantation, Florida, 33324, United States
UPMC Hillman Cancer Center
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING

Miami, Florida, 33136, United States

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