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New drug cocktail targets Hard-to-Treat HER2 cancers

NCT ID NCT04585958

First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 43 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 is a smart drug that delivers chemotherapy directly to HER2-positive tumor cells, while olaparib blocks cancer cells from repairing their DNA. The study aims to find the safest dose and see if the combo can shrink tumors. About 55 adults with metastatic or platinum-resistant ovarian cancer are being enrolled.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact

    Contact Phone: •••-•••-••••

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

    Contact

    Contact Phone: •••-•••-••••

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

    Contact

    Contact Phone: •••-•••-••••

  • Mayo Clinic Hospital in Arizona

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

    Contact

    Contact Phone: •••-•••-••••

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact

    Contact Phone: •••-•••-••••

  • University of Pittsburgh Cancer Institute (UPCI)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

    Contact

    Contact Phone: •••-•••-••••

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 drug that targets HER2 and delivers chemotherapy) and olaparib (a drug that blocks DNA repair)

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 a very early Phase I trial with only 55 people, so the main goal is safety and dosing—not yet proof of effectiveness. Side effects from combining two strong drugs are unknown.

Conditions

The condition(s) this trial relates to.

cancer Neoplasm Metastasis ovarian serous adenocarcinoma

As listed by the trial registrant

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