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A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.
There are multiple cohorts in this trial: * 5 tumor specific cohorts with HER2 overexpression/amplification (cervical cancer, uterine cancer, biliary tract cancer, urothelial cancer, and non-squamous non-small cell lung cancer \[NSCLC\]) * 2 tumor specific cohorts with HER2 mutations (non-squamous NSCLC and breast cancer) * 2 cohorts which will enroll all other HER2 amplified/overexpressed solid tumor types (except breast cancer, gastric or gastroesophageal junction adenocarcinoma \[GEC\], and colorectal cancer \[CRC\]) or HER2-mutated solid tumor types.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
HonorHealth
Phoenix, Arizona, United States
HonorHealth
Tempe, Arizona, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
City of Hope at Huntington Beach
Huntington Beach, California, United States
City of Hope at Irvine Sand Canyon
Irvine, California, United States
Koman Family Outpatient Pavilion
La Jolla, California, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, United States
UC San Diego Moores Cancer Center- Investigational Drug Services
La Jolla, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
City of Hope at Long Beach Worsham
Long Beach, California, United States
Start Date
January 11, 2021
Primary Completion Date
November 1, 2023
Completion Date
April 30, 2026
Last Updated
December 19, 2025
217
ACTUAL participants
tucatinib
DRUG
trastuzumab
DRUG
fulvestrant
DRUG
Lead Sponsor
Seagen, a wholly owned subsidiary of Pfizer
NCT07146646
NCT06230471
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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 ConditionsNCT06653192