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

a study on Uterine Neoplasms Cervical Cancer Biliary Tract Cancer Urologic Neoplasms Lung Cancer Non-Small Cell Lung Cancer Breast Cancer HER2 Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Rana McKay (ucsd)
Headshot of Rana McKay
Rana McKay

Description

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.

Official Title

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

Details

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.

Keywords

Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms, Carcinoma, Non-Small-Cell Lung, HER2 Mutations Breast Neoplasms, 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, Neoplasms, Breast Neoplasms, Trastuzumab, Fulvestrant, Tucatinib, Tucatinib + Trastuzumab (+ Fulvestrant)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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/m2 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.

Locations

  • UC San Diego / Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Pacific Shores Medical Group accepting new patients
    Long Beach California 90813 United States

Lead Scientist at UC Cancer

  • Rana McKay (ucsd)
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 182 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT04579380
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 270 study participants
Last Updated