Trial Title:
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
NCT ID:
NCT04579380
Condition:
Uterine Neoplasms
Uterine Cervical Neoplasms
Biliary Tract Neoplasms
Urologic Neoplasms
Carcinoma, Non-Small-Cell Lung
HER2 Mutations Breast Neoplasms
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Uterine Cervical Neoplasms
Biliary Tract Neoplasms
Uterine Neoplasms
Urologic Neoplasms
Trastuzumab
Fulvestrant
Tucatinib
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
tucatinib
Description:
300 mg orally twice daily
Arm group label:
Tucatinib + Trastuzumab (+ Fulvestrant)
Other name:
TUKYSA, ARRY-380, ONT-380
Intervention type:
Drug
Intervention name:
trastuzumab
Description:
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
Arm group label:
Tucatinib + Trastuzumab (+ Fulvestrant)
Other name:
Herceptin
Intervention type:
Drug
Intervention name:
fulvestrant
Description:
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.
Arm group label:
Tucatinib + Trastuzumab (+ Fulvestrant)
Other name:
Faslodex
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Oncology Associates, PC - HAL
Address:
City:
Goodyear
Zip:
85395
Country:
United States
Facility:
Name:
HonorHealth
Address:
City:
Phoenix
Zip:
85016
Country:
United States
Facility:
Name:
Mayo Clinic Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Facility:
Name:
Arizona Cancer Center / University of Arizona
Address:
City:
Tucson
Zip:
85724
Country:
United States
Facility:
Name:
UC San Diego / Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Facility:
Name:
Pacific Shores Medical Group
Address:
City:
Long Beach
Zip:
90813
Country:
United States
Facility:
Name:
Rocky Mountain Cancer Centers
Address:
City:
Boulder
Zip:
80303
Country:
United States
Facility:
Name:
Regional Cancer Care Associates
Address:
City:
Manchester
Zip:
06040
Country:
United States
Facility:
Name:
Lombardi Cancer Center / Georgetown University Medical Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Facility:
Name:
H. Lee Moffitt Cancer Center and Research Institute
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
University Cancer & Blood Center, LLC
Address:
City:
Athens
Zip:
30607
Country:
United States
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
HealthPartners Institute
Address:
City:
Saint Louis Park
Zip:
55416
Country:
United States
Facility:
Name:
Washington University in St Louis
Address:
City:
Saint Louis
Zip:
63108
Country:
United States
Facility:
Name:
Nebraska Cancer Specialists
Address:
City:
Omaha
Zip:
68130
Country:
United States
Facility:
Name:
NYU Langone Hospital
Address:
City:
Mineola
Zip:
11501
Country:
United States
Facility:
Name:
NYU Langone Hospital
Address:
City:
New York
Zip:
10016
Country:
United States
Facility:
Name:
Mount Sinai Medical Center
Address:
City:
New York
Zip:
10029
Country:
United States
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
Case Western Reserve University / University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Facility:
Name:
James Cancer Hospital / Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Facility:
Name:
Prisma Health
Address:
City:
Greenville
Zip:
29605
Country:
United States
Facility:
Name:
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Texas Oncology - West Texas
Address:
City:
Abilene
Zip:
79606
Country:
United States
Facility:
Name:
Texas Oncology, P.A. - Dallas
Address:
City:
Dallas
Zip:
75246
Country:
United States
Facility:
Name:
MD Anderson Cancer Center / University of Texas
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Texas Oncology - Waco
Address:
City:
Waco
Zip:
76712
Country:
United States
Facility:
Name:
Huntsman Cancer Institute/University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Facility:
Name:
Virginia Cancer Specialists, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
Seattle Cancer Care Alliance / University of Washington
Address:
City:
Seattle
Zip:
98109
Country:
United States
Facility:
Name:
Northwest Cancer Specialists, P.C.
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Facility:
Name:
Carbone Cancer Center / University of Wisconsin
Address:
City:
Madison
Zip:
53792
Country:
United States
Facility:
Name:
Cliniques Universitaires Saint Luc
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Facility:
Name:
Grand Hopital de Charleroi
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Facility:
Name:
Universitair Ziekenhuis Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Facility:
Name:
Academisch Ziekenhuis Groeninge
Address:
City:
Kortrijk
Zip:
8500
Country:
Belgium
Facility:
Name:
CHU de Liege
Address:
City:
Liege
Zip:
4000
Country:
Belgium
Facility:
Name:
AZ Sint-Maarten
Address:
City:
Mechelen
Zip:
2800
Country:
Belgium
Facility:
Name:
Charite Universitatsmedizin Berlin
Address:
City:
Berlin
Zip:
12203
Country:
Germany
Facility:
Name:
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20132
Country:
Italy
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori
Address:
City:
Monza
Zip:
20900
Country:
Italy
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-Ku
Zip:
104-0045
Country:
Japan
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Facility:
Name:
St. Marianna University School of Medicine
Address:
City:
Kawasaki-shi
Zip:
2168511
Country:
Japan
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Facility:
Name:
Kindai University Hospital
Address:
City:
Osakasayama
Zip:
589-8511
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
81004
Country:
Japan
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Boramae Medical Center
Address:
City:
Seoul
Zip:
07671
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Facility:
Name:
Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066 WX
Country:
Netherlands
Facility:
Name:
Med Polonia Sp. z o. o.
Address:
City:
Poznan
Zip:
60-693
Country:
Poland
Facility:
Name:
Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
L'Institut Catala d'Oncologia
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Hospital Clinico Universitario de Santiago de Compostela
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Facility:
Name:
The Royal Marsden Hospital
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Facility:
Name:
Sarah Cannon Research Institute UK
Address:
City:
London
Zip:
W1G 6AD
Country:
United Kingdom
Facility:
Name:
The Royal Marsden Hospital (Surrey)
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Facility:
Name:
Guy's Hospital
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Start date:
January 11, 2021
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Seagen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04579380
