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New drug shows promise for rare HER2-Mutated cancers

NCT ID NCT04639219

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests a drug called trastuzumab deruxtecan (T-DXd) in 102 adults with advanced solid tumors that have specific HER2 mutations. The cancers include types like colorectal, gastric, and ovarian, among others. The goal is to see if the drug can shrink tumors or slow their growth. Participants must have already tried other treatments or have no good options left.

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 (T-DXd)
What this could lead to
If successful, this could provide a new treatment option for people with hard-to-treat cancers that have specific HER2 mutations, regardless of where the cancer started.
What could go wrong
This is a mid-stage trial with only 102 participants and no comparison group. The drug may not work for all mutation types, and side effects like lung inflammation or heart problems 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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults ≥18 years old. Other age restrictions may apply as per local regulations. * Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations (S310F, S310Y, G660D, R678Q, D769Y, D769H, V777L, Y772\_A775dup / A775\_G776insYVMA, L755S, G778\_P780dup / P780\_Y781insGSP, T862A, and V842I locally determined by NGS or a validated nucleic acid-based methodology (eg, qPCR, digital PCR) on tumor tissue, who have progressed following prior treatment or who have no satisfactory alternative treatment options. * Prior HER2 targeted therapy is permitted. * All patients must provide an FFPE tumor sample for retrospective central HER2 testing. * LVEF ≥50% * ECOG 0-1 * All patients have measurable target disease assessed by the Investigator based on RECIST v1.1 Exclusion Criteria: * HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma. * HER2 mutant NSCLC. * Medical history of myocardial infarction within 6 months before randomization/enrolment, symptomatic CHF, unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke. * History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening * Corrected QT interval by Fridericia's formula (QTcF) prolongation to \> 470 msec (females) or \> 450 msec (males) based on average of the screening triplicate 12-lead ECG. * Lung-specific intercurrent clinically significant severe illnesses. * History of active primary immunodeficiency, known HIV, active HBV or HCV infection * Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals * Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). * Has spinal cord compression or clinically active central nervous system metastases.

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis

As listed by the trial registrant

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

Advanced solid tumors with HER2 mutation,eg:colorectal,urothelial,gastric, hepatobiliary,endometrial,melanoma,ovarian,cervical,salivary gland,pancreatic,breast

Contacts and locations

Locations

  • Research Site

    Santa Rosa, California, 95403, United States

  • Research Site

    Muncie, Indiana, 47303, United States

  • Research Site

    Boston, Massachusetts, 02115, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Middletown, New Jersey, 07748, United States

  • Research Site

    Commack, New York, 11725, United States

  • Research Site

    Harrison, New York, 10604, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Anderlecht, 1070, Belgium

  • Research Site

    Toronto, CA, M5G 2M9, Canada

  • Research Site

    Copenhagen, 2100, Denmark

  • Research Site

    Bordeaux, 33076, France

  • Research Site

    Lyon, 69008, France

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Milan, 20162, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Suita-shi, 565-0871, Japan

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Madrid, 28050, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Seville, 41013, Spain