Clinical Trials Logo
  1. Home
  2. Brain Metastases
  3. 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)

Brain Metastases Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05673928
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Ecaterina Dumbrava, MD
Phone 713-563-1930
Email eeileana@mdanderson.org
Status Recruiting
Phase Phase 2
Start date May 16, 2023
Completion date March 1, 2029
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04074096 - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis Phase 2
Recruiting NCT04474925 - Pre- Versus Post-operative SRS for Resectable Brain Metastases Phase 3
Recruiting NCT05358340 - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions N/A
Recruiting NCT05559853 - Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Completed NCT03189381 - Pilot Phase 2 Study Whole Brain Radiation Therapy With Simultaneous Integrated Boost for Patients With Brain Metastases N/A
Completed NCT02082587 - Toronto BNB Pilot Study N/A
Terminated NCT01551680 - A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases Phase 1
Terminated NCT00717275 - Study of Temozolomide to Treat Newly Diagnosed Brain Metastases Phase 2
Recruiting NCT05048212 - A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases Phase 2
Recruiting NCT03714243 - Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases N/A
Recruiting NCT05573815 - Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Completed NCT04507217 - Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC Phase 2
Recruiting NCT05452005 - Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06457906 - SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC Phase 3
Completed NCT04170777 - Perfexion Registration Using CBCT
Recruiting NCT03027544 - Tomotherapy for Refractory Brain Metastases N/A
Completed NCT04178330 - Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases N/A
Terminated NCT02187822 - Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases Phase 1
Terminated NCT00538343 - RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases Phase 2