Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms
About this trial
This is an interventional treatment trial for Uterine Neoplasms focused on measuring Cervical cancer, Uterine cancer, Biliary tract cancer, Urothelial cancer, Non-squamous non-small cell lung cancer, Non-squamous NSCLC, Breast cancer, Colorectal cancer, Ampullary cancer, Solid tumors, Solid tumors harboring somatic HER2 mutations, Seattle Genetics
Eligibility 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:
- HER2 overexpression/amplification from fresh or archival tumor tissue or blood
- Known activating HER2 mutations detected in fresh or archival tumor tissue or blood
- 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
- Participants with breast cancer, gastric or gastroesophageal junction adenocarcinoma, or CRC whose disease shows HER2 amplification/overexpression.
- Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma or HER2-mutated gastric or gastroesophageal junction adenocarcinoma without HER2-overexpression/amplification may have received prior trastuzumab
- Known hypersensitivity to any component of the drug formulation of tucatinib or trastuzumab (drug substance, excipients, murine proteins), or any component of the drug formulation of fulvestrant in participants with HR+ HER2-mutated breast cancer
- History of exposure to a 360 mg/m² doxorubicin-equivalent or >720 mg/m^2 epirubicin-equivalent cumulative dose of anthracyclines
- Treatment with any systemic anti-cancer therapy, radiation therapy, major surgery, or experimental agent within ≤3 weeks of first dose of study treatment or are currently participating in another interventional clinical trial.
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
Sites / Locations
- Arizona Oncology Associates, PC - HAL
- HonorHealth
- Mayo Clinic Arizona
- Arizona Cancer Center / University of Arizona
- UC San Diego / Moores Cancer Center
- Pacific Shores Medical Group
- Rocky Mountain Cancer Centers
- Regional Cancer Care Associates
- Lombardi Cancer Center / Georgetown University Medical Center
- Mayo Clinic Florida
- H. Lee Moffitt Cancer Center and Research Institute
- University Cancer & Blood Center, LLC
- Massachusetts General Hospital
- Mayo Clinic Rochester
- HealthPartners Institute
- Washington University in St Louis
- Nebraska Cancer Specialists
- NYU Langone Hospital
- NYU Langone Hospital
- Mount Sinai Medical Center
- Duke University Medical Center
- Case Western Reserve University / University Hospitals Cleveland Medical Center
- James Cancer Hospital / Ohio State University
- University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
- Prisma Health
- Tennessee Oncology-Nashville/Sarah Cannon Research Institute
- Texas Oncology - West Texas
- Texas Oncology, P.A. - Dallas
- MD Anderson Cancer Center / University of Texas
- Texas Oncology - Waco
- Huntsman Cancer Institute/University of Utah
- Virginia Cancer Specialists, PC
- Seattle Cancer Care Alliance / University of Washington
- Northwest Cancer Specialists, P.C.
- Carbone Cancer Center / University of Wisconsin
- Cliniques Universitaires Saint Luc
- Grand Hopital de Charleroi
- Universitair Ziekenhuis Antwerpen
- Academisch Ziekenhuis Groeninge
- CHU de Liege
- AZ Sint-Maarten
- Charite Universitatsmedizin Berlin
- IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
- Istituto Europeo di Oncologia
- Azienda Socio Sanitaria Territoriale di Monza. Ospedale San Gerardo
- National Cancer Center Hospital
- National Cancer Center Hospital East
- St. Marianna University School of Medicine
- Aichi Cancer Center
- Kindai University Hospital
- The Cancer Institute Hospital of JFCR
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Samsung Medical Center
- Seoul National University Boramae Medical Center
- Severance Hospital, Yonsei University Health System
- Netherlands Cancer Institute
- Med Polonia Sp. z o. o.
- Hospital Universitario Vall d'Hebron
- L'Institut Catala d'Oncologia
- Hospital Universitario 12 de Octubre
- Hospital Clinico Universitario de Santiago de Compostela
- Hospital Clinico Universitario de Valencia
- The Royal Marsden Hospital
- Sarah Cannon Research Institute UK
- The Royal Marsden Hospital (Surrey)
- Guy's Hospital
Arms of the Study
Arm 1
Experimental
Tucatinib + Trastuzumab (+ Fulvestrant)
Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)