Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) for Patients with HER2-positive Metastatic Solid Tumors and Brain Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05673928

Provider View

This clinical trial is exploring whether the combination of two drugs, tucatinib and ado-trastuzumab emtansine (T-DM1), can help control solid tumors that have spread to the brain in patients with HER2-positive cancer.

Patient Parameters

Program Overview

The aim of this study is to find out if the drugs tucatinib and ado-trastuzumab emtansine (T-DM1) can effectively treat solid tumors that have spread to the brain in patients with HER2-positive cancer. Researchers are looking at how well these drugs work in the brain, how long the effects last, and how safe the treatment is for patients. They are also studying how the treatment affects the whole body and how long patients live without the cancer getting worse.

Description

This study is focused on patients with HER2-positive metastatic solid tumors that have spread to the brain. The main goal is to see if the combination of tucatinib and T-DM1 can shrink brain tumors and how long this effect lasts. Researchers will also evaluate the safety of this treatment and its impact on tumors outside the brain. They will measure how long patients live without the cancer progressing and overall survival rates. Additionally, the study will explore how the treatment affects cancer cells and identify any markers that predict how well patients respond to the treatment.

Participants will undergo various tests and procedures to monitor their health and the treatment's effectiveness. The study will also look at the effects of the treatment on circulating-free DNA, which can provide insights into how the cancer is responding.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of HER2-positive metastatic solid tumor.
  • Have brain metastases that do not require immediate treatment or have been treated but are progressing.
  • Have at least one measurable brain lesion between 0.5 cm and 3.0 cm.
  • Have measurable disease outside the brain.
  • Have received or not received prior HER2-targeted treatments.
  • Be 18 years or older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have a life expectancy of at least 3 months.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Have a heart function of at least 50%.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Men must agree to use birth control and not donate sperm during and after the study.
  • Be willing to provide informed consent and undergo required biopsies if safe.

Exclusion Criteria

  • Have untreated brain lesions larger than 3.0 cm or requiring immediate treatment.
  • Be using high doses of steroids for brain metastases.
  • Have uncontrolled seizures or neurological symptoms from brain metastases.
  • Have allergies to study drugs or similar compounds.
  • Have received recent cancer treatments that have not resolved to a safe level.
  • Have significant heart or lung disease.
  • Have had a recent heart attack or unstable chest pain.
  • Be unable to undergo MRI scans.
  • Be using certain medications that affect drug metabolism.
  • Have active hepatitis B, hepatitis C, or HIV.
  • Be pregnant, breastfeeding, or planning to become pregnant during the study.
  • Be unable to swallow pills or have significant digestive issues.
  • Have other medical or social factors that could affect safety or compliance.
  • Have had another cancer requiring treatment within the past year.
  • Be eligible for another similar study (HER2CLIMB-02).

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.