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BRIEF TITLE: Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by 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


  • Org Study ID: SGNTUC-019
  • Secondary ID:
  • NCT ID: NCT04579380
  • NCT Alias:
  • Sponsor: Seagen Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting January 11, 2021 Phase 2 Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 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

Criteria:
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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Vicky Kang, MD

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Seagen Trial Information Support

Phone: 8663337436

Email: clinicaltrials@seagen.com

Locations

Facility Status Contact
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona 85016
United States
Recruiting
Pacific Shores Medical Group
Long Beach, California 90813
United States
Recruiting
Northwest Cancer Specialists, P.C.
Vancouver, Washington 98684
United States
Recruiting