Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05673928

A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)

Led by M.D. Anderson Cancer Center · Updated on 2026-01-21

30

Participants Needed

1

Research Sites

302 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

G

Genentech, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

To learn if the study drugs, tucatinib and adotrastuzumab emtansine (T-DM1), can help to control solid tumors that have spread to the brain.

CONDITIONS

Official Title

A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed HER2-positive metastatic solid tumor with HER2 overexpression or amplification.
  • Brain MRI showing untreated brain metastases not needing immediate local therapy or previously treated brain metastases with progression but no immediate local therapy needed.
  • At least one measurable untreated brain lesion 0.5 cm or larger but less than 3.0 cm.
  • Measurable or evaluable extracranial disease.
  • Prior HER2-targeted treatments allowed; breast and gastric cancer patients must have received at least one line of such treatment.
  • Age 18 years or older at consent.
  • ECOG performance status of 0 to 2.
  • Life expectancy of at least 3 months.
  • Adequate blood counts and organ function based on specified lab tests within 28 days before treatment.
  • INR and PTT/aPTT no greater than 1.5 times the upper limit of normal unless on medication that alters these.
  • Left ventricular ejection fraction (LVEF) of 50% or greater within 3 weeks before treatment.
  • Negative pregnancy test for patients of childbearing potential within 3 days before treatment.
  • Agreement to use effective birth control during and for 7 months after treatment if of childbearing potential or able to father children.
  • Written informed consent.
  • Willingness to undergo biopsy if considered safe and feasible.
Not Eligible

You will not qualify if you...

  • Brain MRI showing any untreated brain lesions larger than 3.0 cm or lesions needing immediate local therapy.
  • Use of systemic corticosteroids above 4 mg dexamethasone daily for brain metastasis symptoms.
  • Poorly controlled seizures or neurologic progression from brain metastases despite CNS therapy.
  • Allergic reactions to trastuzumab, tucatinib, or related compounds, except mild manageable reactions.
  • Treatment with systemic anticancer or investigational therapy within 21 days or 5 half-lives before study.
  • Unresolved toxicity from prior cancer treatments above grade 1, except alopecia, neuropathy resolved to grade 2 or less, and resolved mild congestive heart failure.
  • Significant heart or lung disease including arrhythmia, symptomatic or uncontrolled hypertension, symptomatic heart failure, severe dyspnea, or prolonged QT interval.
  • Recent myocardial infarction or unstable angina within 6 months.
  • Unable to undergo contrast brain MRI.
  • Recent use of strong CYP2C8 or CYP3A4 enzyme inhibitors or inducers.
  • Known hepatitis B or C infection or other chronic liver disease.
  • HIV positive status.
  • Pregnant, breastfeeding, or planning pregnancy during and 7 months after treatment.
  • Unable to swallow pills or significant gastrointestinal disease preventing oral medication absorption.
  • Other medical or social conditions that could affect safety or study compliance.
  • Another malignancy requiring systemic treatment within 1 year before study.
  • Eligibility for the HER2CLIMB-02 study (NCT03975647).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

E

Ecaterina Dumbrava, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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