Status and phase
Conditions
Treatments
About
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.
Full description
There are multiple cohorts in this trial:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors
Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available
Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease
Disease progression during or after, or intolerance of, the most recent line of systemic therapy
Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following:
Have measurable disease per RECIST v1.1 criteria according to investigator assessment
Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
Primary purpose
Allocation
Interventional model
Masking
217 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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