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Brief Title: 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

INTRODUCTION

  • Org Study ID: SGNTUC-019
  • Secondary ID: N/A
  • NTC ID: NCT04579380
  • Sponsor: Seagen Inc.

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


  • Overall Status
    Recruiting
  • Start Date
    January 31, 2021
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Confirmed objective response rate (cORR) per investigator assessment

Primary Outcome 1 - Timeframe: From start of treatment up to approximately 2 years

CONDITION

  • Uterine Neoplasms
  • Uterine Cervical Neoplasms
  • Biliary Tract Neoplasms
  • Urologic Neoplasms
  • Carcinoma
  • Non-Small-Cell Lung
  • Breast Neoplasms

ELIGIBILITY


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/m² 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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Vicky Kang, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Vicky Kang, MD

Phone: 8663337436

Email: clinicaltrials@seagen.com

LOCATION

Facility Status Contact
Facility: Pacific Shores Medical Group
Long Beach, California 90813
United States 		Status: Recruiting Contact: N/A

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