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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urologic Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms; Carcinoma, Non-Small-Cell Lung; Biliary Tract Neoplasms; HER2 Mutations Breast Neoplasms
• Intervention / Treatment: Drug: tucatinib; Drug: trastuzumab; Drug: fulvestrant

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Liège, Belgium, 4000
    • CHU de Liège
  • Mechelen, Belgium, 2800
    • AZ Sint-Maarten
  • Hainaut
    • Charleroi, Hainaut, Belgium, B- 6060
      • Grand Hôpital de Charleroi
• Germany
  • Berlin, Germany, 12203
    • Charité Universitätsmedizin Berlin
• Italy
  • Milan
    • Milan, Milan, Italy, 20141
      • Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
• Japan
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • St. Marianna University School of Medicine Hospital
  • Osaka
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Tokyo
    • Cho-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
  • Other
    • Seoul, Other, South Korea, 03722
      • Severance Hospital Yonsei University Health System
• Spain
  • Barcelona, Spain, 08029
    • Cetir Centre Medic
  • Valencia, Spain, 46015
    • Hospital Vithas Valencia 9 de octubre
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia. Fundación Investigación Clínico de Valencia.
  • Valencia, Spain, 46015
    • Ascires Eresa Campanar
  • Other
    • L'Hospitalet de Llobregat, Other, Spain, 8908
      • Institut Catala d'Oncologia Hospitalet
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, SE1 9RT
    • Jonathan Poon
  • London, United Kingdom, W1G 8BJ
    • The Harley Street Clinic
  • London, United Kingdom, W1G 8PP
    • Radiology
  • Budapest
    • London, Budapest, United Kingdom, W1G 6AD
      • Sarah Cannon Research Institute UK
  • Others
    • London, Others, United Kingdom, W1G 7AF
      • Diagnostic Centre
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Honorhealth
    • Tempe, Arizona, United States, 85284
      • Honorhealth
    • Tucson, Arizona, United States, 85719
      • The University of Arizona Cancer Center-North Campus
  • California
    • Huntington Beach, California, United States, 92648
      • City of Hope at Huntington Beach
    • Irvine, California, United States, 92618
      • City of Hope at Irvine Sand Canyon
    • La Jolla, California, United States, 92037
      • UC San Diego Moores Cancer Center
    • La Jolla, California, United States, 92037
      • Koman Family Outpatient Pavilion
    • La Jolla, California, United States, 92037
      • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
    • La Jolla, California, United States, 92037
      • UC San Diego Moores Cancer Center- Investigational Drug Services
    • Long Beach, California, United States, 90813
      • City of Hope at Long Beach Elm
    • Long Beach, California, United States, 90808
      • City of Hope at Long Beach Worsham
    • Newport Beach, California, United States, 92663
      • City of Hope at Newport Beach Lido
    • Torrance, California, United States, 90505
      • City of Hope Torrance
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers
    • Thornton, Colorado, United States, 80260
      • Rocky Mountain Cancer Centers
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Oncology Hematology, PA
    • Saint Louis Park, Minnesota, United States, 55426
      • Metro Minnesota Community Oncology Research Consortium (MMCORC)
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine [Patient Clinics]
    • St Louis, Missouri, United States, 63108
      • Washington University School of Medicine - Obstetrics & Gynecology [Academic Offices)
    • St Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital Investigational Drug Pharmacy (IDS)
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine - Obstetrics & Gynecology
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Oncology Hematology West P.C. dba Nebraska Cancer Specialists
    • Omaha, Nebraska, United States, 68114
      • Oncology Hematology West P.C. dba Nebraska Cancer Specialists
  • New York
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
    • Mineola, New York, United States, 11501
      • Perlmutter Cancer Center at NYU Langone GYN Oncology Associates
    • Mineola, New York, United States, 11501
      • NYU Langone Health - Long Island (Winthrop Hospital)
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center/Duke Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43203
      • OSU Wexner Medical Center, CarePoint East
    • Columbus, Ohio, United States, 43203
      • OSU Wexner Medical Center, Ohio State University Hospital East
    • Columbus, Ohio, United States, 43210
      • OSU Wexner Medical Center, Arther G. James Cancer Hospital, and Solove Research Institute
    • Columbus, Ohio, United States, 43210
      • OSU Wexner Medical Center, Investigational Drug Services(IP Ship to)
    • Columbus, Ohio, United States, 43210
      • Osu Wexner Medical Center, The Ohio State University Hospital
    • Columbus, Ohio, United States, 43221
      • OSU Wexner Medical Center, Martha Morehouse Medical Plaza
    • Columbus, Ohio, United States, 43221
      • OSU Wexner Medical Center, OutPatient Care Upper Arlington
    • Columbus, Ohio, United States, 43212
      • OSU Wexner Medical Center, Stephanie Spielman Comprehensive Breast Center
    • Gahanna, Ohio, United States, 43230
      • OSU Wexner Medical Center, CarePoint Gahanna
    • Hilliard, Ohio, United States, 43026
      • OSU Wexner Medical Center, Gynecologic Oncology at Mill Run
    • Lewis Center, Ohio, United States, 43035
      • OSU Wexner Medical Center, Outpatient Care Lewis Center
    • Orange, Ohio, United States, 44122
      • UH Minoff Health Center at Chagrin Highlands
    • Westerville, Ohio, United States, 43081
      • OSU Wexner Medical Center, Outpatient Care New Albany
  • Oregon
    • Portland, Oregon, United States, 97227
      • Northwest Cancer Specialists, P.C.
    • Portland, Oregon, United States, 97213
      • Northwest Cancer Specialists, P.C.
    • Tigard, Oregon, United States, 97223
      • Northwest Cancer Specialists, P.C.
  • Pennsylvania
    • Washington, Pennsylvania, United States, 15301
      • UPMC Hillman Cancer Center - Washington
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • Prisma Health Cancer Institute
    • Easley, South Carolina, United States, 29640
      • Prisma Health Cancer Institute
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute
    • Greer, South Carolina, United States, 29650
      • Prisma Health Cancer Institute
    • Seneca, South Carolina, United States, 29672
      • Prisma Health Cancer Institute
  • Tennessee
    • Gallatin, Tennessee, United States, 37066
      • Tennessee Oncology, PLLC
    • Hendersonville, Tennessee, United States, 37075
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Shelbyville, Tennessee, United States, 37160
      • Tennessee Oncology, PLLC
  • Texas
    • Abilene, Texas, United States, 79606
      • Texas Oncology-West Texas
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Products Center (IPC)
    • Irving, Texas, United States, 75063
      • US Oncology Investigational Product Center (IPC)
    • Irving, Texas, United States, 75063
      • US Oncology lnvestigational Products Center (IPC)
    • Waco, Texas, United States, 76712
      • Texas Oncology - Central South
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute, University of Utah
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Virginia Cancer Specialists, PC
    • Arlington, Virginia, United States, 22205
      • Virginia Cancer Specialists, PC
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Gainesville, Virginia, United States, 20155
      • Virginia Cancer Specialists, PC
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists, P.C.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Clinical Science Center
    • Madison, Wisconsin, United States, 53715
      • 1 S Park St Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tucatinib + Trastuzumab (+ Fulvestrant); Tucatinib + trastuzumab (+ fulvestrant in hormone-receptor positive HER2-mutant breast cancer only)

Drug: tucatinib; 300 mg orally twice daily; Other Names: TUKYSA, ARRY-380, ONT-380; 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; Other Names: Herceptin; 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.; Other Names: Faslodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Objective Response Rate (cORR) as Assessed by Investigator	Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: at least a greater than or equal to (>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least >=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).	From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Disease Control Rate (DCR) as Assessed by Investigator	DCR was defined as the percentage of participants with confirmed CR, PR, or stable disease (SD or non-CR/non-PD) according to RECIST v1.1 as assessed by investigator. As per RECIST v1.1, CR: disappearance of all target (T) lesions and non-target (NT) lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least >=30 % decrease in the SOD of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. PD: at least >=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is the smallest on study). SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD while on study and cannot have met criteria for PD previously.	From the first dose study treatment until PD or death, whichever occurred first (approximately 52.7 months)
Duration of Response (DOR) as Assessed by Investigator	DOR: time from first documentation of confirmed CR/PR to first documentation of PD according to RECIST v1.1 or death from any cause, whichever occurred earlier. Per RECIST v1.1, CR: disappearance of all T/NT lesions(L). Any pathological lymph nodes (whether T/NT) must have reduction in short axis to <10 mm. PR: at least >=30 % decrease in SOD of TL, taking reference baseline sum diameters. PD: at least >=20% relative increase in SOD of TL taking reference smallest sum on study. Participants who do not have PD & were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD/death occurred after two/more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.	From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)
Progression-Free Survival (PFS) as Assessed by Investigator	PFS was defined as time from the date of treatment initiation to date of PD as per RECIST v1.1 or death from any cause, whichever occurred first . As per RECIST v1.1, PD: least >=20% relative increase in SOD of target lesions taking as reference the smallest sum on study (including baseline sum if that is smallest on study). Participants who do not have PD and were still on study at time of an analysis/ who have started new anticancer treatment/discontinue prior to documentation of PD were censored at date of last adequate response assessment documenting absence of PD. Participants who had PD or death occurred after two or more consecutive missing scheduled response assessments were censored at date of last adequate response assessment of CR, PR, SD,/non-CR/non-PD. Kaplan-Meier method was used for evaluation.	From the first documented CR or PR until the first documentation of PD or death or censoring date, whichever occurred first (approximately 52.7 months)
Overall Survival (OS)	OS was defined as the time from treatment initiation to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). Participants lacking data beyond the day of treatment initiation were censored on the date of treatment initiation (i.e., OS duration of 1 day). Kaplan-Meier method was used for evaluation.	From date of start of study treatment until date of death or censoring date (approximately 52.7 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An AE was any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment.	From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)
Number of Participants With Treatment Emergent Laboratory Test Abnormalities	Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment up to 30 days after the last dose of study treatment. The following laboratory abnormalities were assessed: A-) Hematology: hemoglobin decreased, leukocytes decreased, lymphocytes decreased and increased, neutrophils decreased and platelets decreased; B-) Chemistry: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin decreased and increased, creatinine increased, glomerular filtration rate estimated decreased, glucose decreased, lactate dehydrogenase increased, magnesium increased and decreased, potassium increased and decreased, sodium increased and decreased and total bilirubin increased.	From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 52.7 months)
Number of Participants With Any Dose Modifications Due to AEs	Dose modification included dose hold, dose reduction, or discontinuation of drugs. Dose reductions or treatment interruption/discontinuation were made at the discretion of the investigator.	From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months)
Number of Participants With TEAEs of Special Interest	An adverse event of special interest (AESI) were any serious or nonserious AE that were of scientific or medical concern as defined by the sponsor and specific to the program, for which ongoing monitoring and rapid communication to the sponsor were appropriate. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib, trastuzumab or fulvestrant). AESIs for this study were related to hepatoxicity.	From first dose of the study treatment (Day 1) up to the last dose of study treatment (approximately 52.7 months)
Maximum Concentration (Cmax) of Tucatinib		Cycle 3 Day 1: anytime within 1-4 hours post-dose
Trough Concentration (Ctrough) of Tucatinib		Cycle 3 Day 1: Predose

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Okines AFC, Curigliano G, Mizuno N, Oh DY, Rorive A, Soliman H, Takahashi S, Bekaii-Saab T, Burkard ME, Chung KY, Debruyne PR, Fox JR, Gambardella V, Gil-Martin M, Hamilton EP, Monk BJ, Nakamura Y, Nguyen D, O'Malley DM, Olawaiye AB, Pothuri B, Reck M, Sudo K, Sunakawa Y, Van Marcke C, Yu EY, Ramos J, Tan S, Bieda M, Stinchcombe TE, Pohlmann PR. Tucatinib and trastuzumab in HER2-mutated metastatic breast cancer: a phase 2 basket trial. Nat Med. 2025 Mar;31(3):909-916. doi: 10.1038/s41591-024-03462-0. Epub 2025 Jan 17.
• Nakamura Y, Mizuno N, Sunakawa Y, Canon JL, Galsky MD, Hamilton E, Hayashi H, Jerusalem G, Kim ST, Lee KW, Kankeu Fonkoua LA, Monk BJ, Nguyen D, Oh DY, Okines A, O'Malley DM, Pohlmann P, Reck M, Shin SJ, Sudo K, Takahashi S, Van Marcke C, Yu EY, Groisberg R, Ramos J, Tan S, Stinchcombe TE, Bekaii-Saab T. Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study. J Clin Oncol. 2023 Dec 20;41(36):5569-5578. doi: 10.1200/JCO.23.00606. Epub 2023 Sep 26.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): November 1, 2023
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Colorectal cancer; Solid tumors; Breast cancer; Seattle Genetics; Cervical cancer; Ampullary cancer; Urothelial cancer; Biliary tract cancer; Uterine cancer; Non-squamous NSCLC; Non-squamous non-small cell lung cancer; Solid tumors harboring somatic HER2 mutations
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Uterine Diseases; Genital Diseases, Female; Lung Diseases; Biliary Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Genital Neoplasms, Female; Skin Diseases; Breast Diseases; Uterine Cervical Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Skin and Connective Tissue Diseases; Biliary Tract Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Urologic Neoplasms; Uterine Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Peptides, and Proteins; Proteins; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Trastuzumab; Fulvestrant; tucatinib
• Other Study ID Numbers: SGNTUC-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No