Targeted drug shows promise for rare HER2-Positive cancers
NCT ID NCT04439110
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 Hide 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a phone app help childhood cancer survivors keep track of their health?
- Can a smart drug deliver a One-Two punch to advanced cancers?
- Engineered donor cells could outsmart relapsed myeloma
- Can a new PET tracer reveal hidden immune clues in tumors?
- Can a Triple-Drug cocktail tame resistant myeloma?
- Can a protein calm the immune System's overreaction to cancer treatment?