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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04579380
Other study ID # SGNTUC-019
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 11, 2021
Est. completion date May 31, 2025

Study information

Verified date November 2023
Source Seagen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 217
Est. completion date May 31, 2025
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
tucatinib
300 mg orally twice daily
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
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.

Locations

Country Name City State
Belgium Cliniques Universitaires Saint Luc Brussels Other
Belgium Grand Hopital de Charleroi Charleroi Other
Belgium Universitair Ziekenhuis Antwerpen Edegem Other
Belgium Academisch Ziekenhuis Groeninge Kortrijk Other
Belgium CHU de Liege Liege Other
Belgium AZ Sint-Maarten Mechelen Other
Germany Charite Universitatsmedizin Berlin Berlin Other
Italy IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l Meldola Other
Italy Istituto Europeo di Oncologia Milano Other
Italy Fondazione IRCCS San Gerardo dei Tintori Monza Other
Japan National Cancer Center Hospital Chuo-Ku Other
Japan National Cancer Center Hospital East Kashiwa-shi Other
Japan St. Marianna University School of Medicine Kawasaki-shi Other
Japan Aichi Cancer Center Nagoya-shi Other
Japan Kindai University Hospital Osakasayama Other
Japan The Cancer Institute Hospital of JFCR Tokyo Other
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Other
Korea, Republic of Samsung Medical Center Seoul Other
Korea, Republic of Seoul National University Boramae Medical Center Seoul Other
Korea, Republic of Seoul National University Hospital Seoul Other
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Other
Netherlands Netherlands Cancer Institute Amsterdam Other
Poland Med Polonia Sp. z o. o. Poznan Other
Spain Hospital Universitario Vall d'Hebron Barcelona Other
Spain L'Institut Catala d'Oncologia L'Hospitalet de Llobregat Other
Spain Hospital Universitario 12 de Octubre Madrid Other
Spain Hospital Clinico Universitario de Santiago de Compostela Santiago de Compostela Other
Spain Hospital Clinico Universitario de Valencia Valencia Other
United Kingdom Guy's Hospital London
United Kingdom Sarah Cannon Research Institute UK London Other
United Kingdom The Royal Marsden Hospital London Other
United Kingdom The Royal Marsden Hospital (Surrey) Sutton Other
United States Texas Oncology - West Texas Abilene Texas
United States University Cancer & Blood Center, LLC Athens Georgia
United States Massachusetts General Hospital Boston Massachusetts
United States Rocky Mountain Cancer Centers Boulder Colorado
United States Case Western Reserve University / University Hospitals Cleveland Medical Center Cleveland Ohio
United States James Cancer Hospital / Ohio State University Columbus Ohio
United States Texas Oncology, P.A. - Dallas Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Virginia Cancer Specialists, PC Fairfax Virginia
United States Arizona Oncology Associates, PC - HAL Goodyear Arizona
United States Prisma Health Greenville South Carolina
United States MD Anderson Cancer Center / University of Texas Houston Texas
United States Mayo Clinic Florida Jacksonville Florida
United States UC San Diego / Moores Cancer Center La Jolla California
United States Pacific Shores Medical Group Long Beach California
United States Carbone Cancer Center / University of Wisconsin Madison Wisconsin
United States Regional Cancer Care Associates Manchester Connecticut
United States NYU Langone Hospital Mineola New York
United States Tennessee Oncology-Nashville/Sarah Cannon Research Institute Nashville Tennessee
United States Mount Sinai Medical Center New York New York
United States NYU Langone Hospital New York New York
United States Nebraska Cancer Specialists Omaha Nebraska
United States HonorHealth Phoenix Arizona
United States Mayo Clinic Arizona Phoenix Arizona
United States University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Rochester Minnesota
United States Washington University in St Louis Saint Louis Missouri
United States HealthPartners Institute Saint Louis Park Minnesota
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Seattle Cancer Care Alliance / University of Washington Seattle Washington
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States Arizona Cancer Center / University of Arizona Tucson Arizona
United States Northwest Cancer Specialists, P.C. Vancouver Washington
United States Texas Oncology - Waco Waco Texas
United States Lombardi Cancer Center / Georgetown University Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Seagen Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Confirmed objective response rate (cORR) per investigator assessment cORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 From start of treatment up to approximately 2 years
Secondary Disease control rate (DCR) per investigator assessment DCR is defined as the proportion of participants with confirmed CR, confirmed PR, or stable disease according to RECIST v1.1 From start of treatment up to approximately 2 years
Secondary Duration of response (DOR) per investigator assessment DOR is defined as the time from first documentation of objective response of confirmed CR or confirmed PR to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. From start of treatment up to approximately 2 years
Secondary Progression-free survival (PFS) per investigator assessment PFS is defined as the time from the date of treatment initiation to the date of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first. From start of treatment up to approximately 2 years
Secondary Overall survival (OS) OS is defined as the time from treatment initiation to death due to any cause. From start of treatment up to approximately 4 years
Secondary Incidence of adverse events (AEs) Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. From start of treatment up to approximately 2 years
Secondary Incidence of laboratory abnormalities To be summarized using descriptive statistics. From start of treatment up to approximately 2 years
Secondary Incidence of dose alterations From start of treatment up to approximately 2 years
Secondary Maximum concentration (Cmax) To be summarized using descriptive statistics. Approximately 4 months, during first 6 cycles of treatment
Secondary Trough concentration (Ctrough) To be summarized using descriptive statistics. Approximately 4 months, during first 6 cycles of treatment
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