Study Sponsor: Seagen

Study Drug Name: Tucatinib (in Combination with Trastuzumab Deruxtecan)

Drug Class: Tucatinib blocks a protein called HER2, which may help keep cancer cells from growing and may kill them. It is a type of tyrosine kinase inhibitor. Also called Tukysa.

Route of administration: Tucatinib is an oral drug. Trastuzumab Deruxtecan is given through an IV infusion.

Duration of Study: up to three years

Target Patient Cancer Type: Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Key Inclusion Criteria:

• At least 18 years old
• HER2+ breast cancer
• Received 2 or more anti-HER2 based drugs in the past
• Patients with brain metastases are eligible and have several additional criteria to check for stability and safety. Your medical records, including MRI and radiation notes, will be reviewed to confirm this.

Key Exclusion Criteria:

• Previously treated with:
  • Lapatinib or neratinib within 12 months of starting study treatment
  • Tucatinib or enrolled on a tucatinib clinical trial
  • Any investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) (eg, afatinib) at any time previously
  • Trastuzumab deruxtecan or another antibody-drug conjugate (ADC) consisting of an exatecan derivative
  • Any systemic anti-cancer therapy (including hormonal therapy) or experimental agent ≤21 days of first dose of study treatment
  • o Treatment with non-CNS (brain) radiation within 7 days of starting study treatment
  • Major surgery planned within 28 days of first dose of study treatment
• Currently participating in another interventional clinical trial
• Diagnosed with any of the following:
  • HIV
  • Heart attack within 6 months of beginning study treatment
  • Major lung disease (like Interstitial Lung Disease)
  • Hepatitis B
  • Hepatitis C if not adequately treated
  • Current active or uncontrolled infection
  • Pregnant, breastfeeding, or planning to become pregnant while in the trial

Diversity Statement:

Seagen is dedicated to our goal of ensuring that all patients are represented in our clinical trials. It is important to Seagen that the therapies we make improve the lives of all people with cancer, including those who have been historically underrepresented due to their sex, race, ethnicity, or age.

Brief Summary:

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has 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 deruxtecan.

Full Protocol Title: A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer (HER2CLIMB-04)

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