Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
Running, not enrolling · Phase 2
Conditions studied: Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms, Carcinoma, Non-Small-Cell Lung, HER2 Mutations Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT04579380
- Run by
- Seagen, a wholly owned subsidiary of Pfizer
- People needed
- 217
- Starts
- 2021-01-11
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2025-12-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
- City of Hope at Long Beach Elm — Long Beach, California, United States
- City of Hope at Newport Beach Lido — Newport Beach, California, United States
- City of Hope Torrance — Torrance, California, United States
- Rocky Mountain Cancer Centers — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers — Boulder, Colorado, United States
- Rocky Mountain Cancer Centers — Thornton, Colorado, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Minnesota Oncology Hematology, PA — Coon Rapids, Minnesota, United States
- Metro Minnesota Community Oncology Research Consortium (MMCORC) — Saint Louis Park, Minnesota, United States
- Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices) — St Louis, Missouri, United States
- Barnes-Jewish Hospital Investigational Drug Pharmacy (IDS) — St Louis, Missouri, United States
- Washington University School of Medicine - Obstetrics & Gynecology — St Louis, Missouri, United States
- Washington University School of Medicine [Patient Clinics] — St Louis, Missouri, United States
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
- HonorHealth — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.