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Targeted drug shows promise for rare HER2-Positive cancers

NCT ID NCT04439110

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called ado-trastuzumab emtansine in people whose cancers have too many HER2 receptors (HER2 amplification), but not breast or stomach cancers. The drug combines an antibody that targets HER2 with a chemotherapy agent to kill cancer cells. Researchers want to see if it can shrink tumors or stop them from growing. About 38 adults with advanced or hard-to-treat cancers are taking part.

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

38 people

The number who actually took part.

Started

Aug 2015

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol * Patients' tumor sample must have HER2 amplification \> 7 based on targeted custom Ampliseq panel on the Ion Torrent Personal Genome Machine (PGM) * Hemoglobin \>= 9.0 g/dL (which may be reached by transfusion) * Patients will be allowed if on anticoagulation (except warfarin and other coumarin derivatives) or on aspirin 81 mg by mouth daily. Additional monitoring while on anticoagulation will be based on institutional guidelines and/or physician discretion. However, patients will not be allowed if on long acting anti-platelet agents such as clopidogrel * Patients must have an electrocardiogram (ECG) within 4 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block) * Patients must have echocardiography (ECHO) or nuclear study (multigated acquisition scan \[MUGA\] or First Pass) within 4 weeks prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) \< 50% to be eligible * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after completion of study Exclusion Criteria: * Patients with a diagnosis of breast cancer or gastric/gastroesophageal junction (GEJ) cancer will be excluded * Patients must not have known hypersensitivity to ado-trastuzumab emtansine or compounds of similar chemical or biologic composition * Patients with current peripheral neuropathy of grade 3 or greater (National Cancer Institute \[NCI\]-Common Toxicity Criteria \[CTC\], version 4.0) will be excluded * Neuropathy assessment and grade assignment will be based on history (location, duration, balance and gait, effect on activity of daily living \[ADLs\]) and physical exam * Patient must not have had any of the prior therapies: * Food and Drug Administration (FDA) approved: * Trastuzumab * Pertuzumab * Ado-trastuzumab emtansine * Investigational: * Margetuximab * PF-05280014 (Pfizer, Trastuzumab Biosimilar) * CT-P6 (Celltrion, Trastuzumab Biosimilar) * ABP-980 (Amgen, Trastuzumab Biosimilar)

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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.

Contacts and locations

Locations

  • ECOG-ACRIN Cancer Research Group

    Philadelphia, Pennsylvania, 19103, United States

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