NCT04439110Active, not recruitingPhase 2
Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q)
MATCH Treatment Subprotocol Q: Ado-trastuzumab Emtansine in Patients With Tumors With HER2 Amplification (Except Breast and Gastric/Gastro-Esophageal Junction (GEJ) Adenocarcinomas)
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
This phase II MATCH treatment trial identifies the effects of ado-trastuzumab emtansine in patients whose cancer has a genetic change called HER2 amplification. Ado-trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab is a form of "targeted therapy", because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers DM1 to kill them. Researchers hope to learn if the study drug will shrink this type of cancer or stop its growth.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 18 Jun 2020
- Start date
- 12 Aug 2015
- Primary completion date
- 9 Mar 2019
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Multiple myeloma
- NCT number
- NCT04439110
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 38
- From 12 Aug 2015 to the primary completion date, 9 Mar 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.