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

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    270
  • sponsor
    Seagen Inc.
Updated on 18 September 2021
systemic therapy
measurable disease
breast cancer
endocrine therapy
hormone therapy
HER2
trastuzumab
cancer chemotherapy
targeted therapy
fulvestrant
erbb2
mammogram
metastatic cervical cancer

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, GEC, and CRC) or HER2-mutated solid tumor types.

Details
Condition Non-Small Cell Lung Cancer, Cervical Cancer, urinary tract neoplasm, Disorders of cervix NOS, Disorder of uterus NOS, Uterine Cancer, Breast Cancer, Biliary neoplasm, Genitourinary Neoplasms, Neoplasm of unspecified nature of digestive system, Urothelial Tract Cancer, Uterine Disorders, Biliary Tract Cancer, Digestive System Neoplasms, Genitourinary Cancer, Urologic Cancer, breast tumors, tumor of the breast, breast tumor, cervical neoplasm
Treatment Trastuzumab, fulvestrant, Tucatinib
Clinical Study IdentifierNCT04579380
SponsorSeagen Inc.
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors
Participants with disease types other than breast cancer, biliary tract cancer, non-squamous NSCLC, and cervical cancer: Disease progression on or after the most recent systemic therapy for locally-advanced unresectable or metastatic disease
Participants with any breast cancer subtype
Must have HER2-mutated disease which does not display HER2 overexpression/amplification
Must have progressed on or after 1 prior line of treatment (chemotherapy, endocrine therapy, or targeted therapy) for locally-advanced unresectable or metastatic breast cancer
Participants with metastatic HR+ HER2-mutated disease must have received a prior CDK4/6 inhibitor in the metastatic setting
Participants with biliary tract cancer: must have completed 1 prior line of treatment (chemotherapy, endocrine therapy, or targeted therapy)
Participants with non-squamous NSCLC: has relapsed from or is refractory to standard treatment or for which no standard treatment is available
Participants with cervical cancer
Participants with metastatic cervical cancer must have progressed on or after 1 prior line of systemic therapy in the metastatic setting
Participants with locally advanced unresectable cervical cancer must have progressed on or after 1 prior lines 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, GEC, or CRC whose disease shows HER2 amplification/overexpression
Previous treatment with HER2-directed therapy; participants with uterine serous carcinoma 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/m doxorubicin-equivalent or >720 mg/m^2 epirubicin-equivalent cumulative dose of anthracyclines
Treatment with any systemic anti-cancer therapy, radiation therapy, 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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