New hope for Hard-to-Treat cancers: enhertu studied in 20+ tumor types
NCT ID NCT07124000
First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 7 times
Summary
This study is testing the drug T-DXd (Enhertu) in 100 adults with advanced HER2-positive solid tumors who have already tried other treatments and have no good options left. The goal is to see how well the drug works in real-world settings, including how many patients respond and for how long. The study covers many cancer types, such as bladder, cervical, ovarian, and pancreatic cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trastuzumab deruxtecan (Enhertu)
- What this could lead to
- If successful, this could show that T-DXd is an effective treatment option for many types of HER2-positive cancers that have stopped responding to other therapies.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less definitive. The drug may not work for all tumor types, and side effects like lung inflammation are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will enroll patients for whom a clinician decision has been made for treatment with T-DXd as part of routine clinical practice and in line with the FDA label, but who have not yet started therapy with T-DXd
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults aged ≥18 years 2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors); 3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label; 4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent; 5. Patients who are willing and able to provide a signed and dated informed consent. Exclusion Criteria: 1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies; 2. Prior T-DXd therapy; 3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd. 4. Patient is participating in a clinical trial at time of enrolment
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
18 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
RECRUITINGBirmingham, Alabama, 35243, United States
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Research Site
RECRUITINGBullhead City, Arizona, 86442, United States
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Research Site
RECRUITINGCasa Grande, Arizona, 85122, United States
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Research Site
RECRUITINGSan Diego, California, 92123, United States
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Research Site
RECRUITINGBoulder, Colorado, 80309, United States
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Research Site
RECRUITINGCoral Springs, Florida, 33065, United States
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Research Site
RECRUITINGSt. Petersburg, Florida, 33714, United States
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Research Site
RECRUITINGWest Palm Beach, Florida, 33401, United States
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Research Site
RECRUITINGDecatur, Illinois, 62526, United States
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Research Site
RECRUITINGTopeka, Kansas, 66604, United States
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Research Site
RECRUITINGFarmington, New Mexico, 87401, United States
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Research Site
RECRUITINGDurham, North Carolina, 27708, United States
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Research Site
RECRUITINGWilson, North Carolina, 27893, United States
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Research Site
RECRUITINGCanton, Ohio, 44718, United States
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Research Site
RECRUITINGMaumee, Ohio, 43537, United States
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Research Site
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Research Site
RECRUITINGNashville, Tennessee, 37203, United States
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Research Site
RECRUITINGDallas, Texas, 75390, United States
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