New drug DS-8201a shows promise in targeting Hard-to-Treat cancers
NCT ID NCT04294628
First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 35 times
Summary
This early-phase trial is testing a drug called DS-8201a in 62 adults with advanced HER2-positive solid tumors that have not responded to standard treatments. The drug works by attaching to the HER2 protein on cancer cells and damaging their DNA, which may kill the cells. Researchers will take tumor samples before and after treatment to see how the drug affects proteins and immune cells in the tumor.
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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.
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
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Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
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National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, 20892, United States
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
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 protein on cancer cells and damages their DNA)
What this could lead to
If successful, this could help develop better treatments for advanced HER2-positive cancers that have stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1) pilot study with only 62 participants, so results may not apply to all patients. The drug may not work as hoped or could cause side effects.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.