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ACTIVE NOT RECRUITING

NCT04579380

PHASE2

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

217

Start Date

2021-01-11

Completion Date

2026-04-30

Last Updated

2025-12-19

Healthy Volunteers

Conditions

Uterine Neoplasms Uterine Cervical Neoplasms Biliary Tract Neoplasms Urologic Neoplasms Carcinoma, Non-Small-Cell Lung HER2 Mutations Breast Neoplasms

Interventions

DRUG

tucatinib

300 mg orally twice daily

DRUG

trastuzumab

Given into the vein (intravenously; IV). 8mg/kg IV on Cycle 1 Day 1, and 6mg/kg every 21 days starting on Cycle 2 Day 1

DRUG

fulvestrant

Given into the muscle (intramuscular; IM) once every 4 weeks starting from Cycle 1 Day 1, plus one dose on Cycle 1 Day 15. Only administered to participants with hormone-receptor positive breast cancer.

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.

Locations (106)

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

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

NYU Langone Health - Long Island (Winthrop Hospital)

Mineola, New York, United States

Perlmutter Cancer Center at NYU Langone GYN Oncology Associates

Mineola, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

NYU Langone Medical Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Duke University Medical Center/Duke Cancer Center

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

OSU Wexner Medical Center, CarePoint East

Columbus, Ohio, United States

OSU Wexner Medical Center, Ohio State University Hospital East

Columbus, Ohio, United States

OSU Wexner Medical Center, Arther G. James Cancer Hospital, and Solove Research Institute

Columbus, Ohio, United States

OSU Wexner Medical Center, Investigational Drug Services(IP Ship to)

Columbus, Ohio, United States

Osu Wexner Medical Center, The Ohio State University Hospital

Columbus, Ohio, United States

OSU Wexner Medical Center, Stephanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

OSU Wexner Medical Center, Martha Morehouse Medical Plaza

Columbus, Ohio, United States

OSU Wexner Medical Center, OutPatient Care Upper Arlington

Columbus, Ohio, United States

OSU Wexner Medical Center, CarePoint Gahanna

Gahanna, Ohio, United States

OSU Wexner Medical Center, Gynecologic Oncology at Mill Run

Hilliard, Ohio, United States

OSU Wexner Medical Center, Outpatient Care Lewis Center

Lewis Center, Ohio, United States

UH Minoff Health Center at Chagrin Highlands

Orange, Ohio, United States

OSU Wexner Medical Center, Outpatient Care New Albany

Westerville, Ohio, United States

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Northwest Cancer Specialists, P.C.

Tigard, Oregon, United States

UPMC Hillman Cancer Center - Washington

Washington, Pennsylvania, United States