Loading clinical trials...

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) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT05673928•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

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

Detailed Description

Primary Objectives: ● To determine the intracranial antitumor activity of the tucatinib and ado-trastuzumab emtansine (T- bination per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) in patients with huma Key Secondary Objectives: * To determine the intracranial antitumor activity of the tucatinib and T-DM1 combination per the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria in patients with HER2-positive metastatic solid tumors and brain metastases. * To evaluate the duration of intracranial response of the tucatinib and T-DM1 combination in patients with HER2-positive metastatic solid tumors and brain metastases. Other Secondary Objectives: * To evaluate the safety and tolerability of the tucatinib and T-DM1 combination in patients with HER2-positive metastatic solid tumors and brain metastases. * To evaluate the systemic antitumor activity of the tucatinib and T-DM1 combination per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with HER2-positive metastatic solid tumors and brain metastases. * To evaluate progression-free survival (PFS) in patients with HER2-positive metastatic solid tumors and brain metastases receiving the tucatinib and T-DM1 combination. * To evaluate overall survival (OS) in patients with HER2-positive metastatic solid tumors and brain metastases receiving the tucatinib and T-DM1 combination. * To evaluate the duration of response to the tucatinib and T-DM1 combination per the RECIST v1.1 in patients with HER2-positive metastatic solid tumors and brain metastases. * To evaluate the clinical benefit rate of the tucatinib and T-DM1 combination per the RECIST v1.1 in patients with HER2-positive metastatic solid tumors and brain metastases. Exploratory Objectives: * To assess the effects of the tucatinib and T-DM1 combination on cell proliferation and apoptosis. * To evaluate predictive and pharmacodynamic (PD) biomarkers of response and resistance to the tucatinib and T-DM1 combination. * To assess the effects of the tucatinib and T-DM1 combination on circulating-free DNA (cfDNA) dynamics.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed HER2-positive metastatic solid tumor. HER2 positivity defined as HER2 overexpression by immunohistochemistry (IHC) 3+ or 2+ and fluorescence in situ hybridization (FISH) positive and/or HER2 amplification by in situ hybridization (ISH) or next generation sequencing (NGS) and/or activating ERBB2 mutation(s) (verified by MDACC Precision Oncology Decision Support).
•2. Patients must have one of the following on the screening brain MRI:
•* Untreated brain metastases not requiring immediate local CNS therapy
•* Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy
•* At least one measurable untreated brain lesion ≥0.5 cm and \<3.0 cm in the longest axis
•* Prior SRS radiosurgery (must be completed within 7 days of study treatment initiation) is allowed as long as the previous treatment volume does not overlap with the current targets.
•3. Measurable (per the RECIST v1.1) or evaluable extracranial disease.
•4. Prior treatment with HER2-targeted treatments such as trastuzumab, pertuzumab, T-DM1, neratinib, lapatinib, or tucatinib is allowed, but not required. Patients with breast and gastric cancer must have received at least 1 line of HER2 targeted treatment.
•5. Age ≥18 years at the time of consent.
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Appendix B).
+47 more criteria

Exclusion Criteria

•1. Patients must not have any of the following on the screening brain MRI:
•* Any untreated brain lesions \>3.0 cm in size

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

May 16, 2023

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2029

Last Updated

January 21, 2026

Enrollment

ESTIMATED participants

Conditions

Metastatic Solid TumorBrain Metastases

Interventions

Trastuzumab emtansine

DRUG

Tucatinib

DRUG

Contacts

Ecaterina Dumbrava, MD

CONTACT

713-563-1930 eeileana@mdanderson.org

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

View study

RECRUITINGPHASE1

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

NCT06716138

Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements