Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seagen Inc.
With
National Cancer Institute (NCI)
Academic and Community Cancer Research United
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically and/or cytologically documented adenocarcinoma of the colon or rectum that is metastatic and/or unresectable
Unless contraindicated, participants must have received and failed regimens containing the following agents: fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ramucirumab, or ziv-aflibercept), and an anti-PD-(L)1 therapy (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins or is MSI-High.
Have progression of unresectable or metastatic CRC after the last systemic therapy, or be intolerant of last systemic therapy
Have RAS wild-type in primary or metastatic tumor tissue, based on expanded RAS testing
Willing and able to provide the most recently available tissue blocks obtained prior to treatment initiation. If archival tissue is not available, then a newly-obtained baseline biopsy of an accessible tumor
Have confirmed HER2-positive mCRC, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Act (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory, meeting at least one of the following criteria:
* HER2+ overexpression (3+ immunohistochemistry \[IHC\]) by an FDA-approved or Conformité Européene (CE)-marked HER2 ICH test
* HER2 (ERBB2) amplification by CLIA-certified or ISO-accredited next generation sequencing (NGS) sequencing assay
Have radiographically measurable disease assessable by RECIST 1.1, with at least one site of disease that is measurable and that has not been previously irradiated; or, if the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
Life expectancy greater than 3 months
Have adequate hematological, hepatic, renal, coagulation, and cardiac function
You may not be if
Previous treatment with anti-HER2 targeting therapy
Previous treatment with any systemic anticancer therapy, non-central nervous system radiation, or experimental agent within 3 weeks of first dose of study treatment
Toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:
* Alopecia and neuropathy, which must have resolved to ≤ Grade 2
* Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence, and must have resolved completely
* Anemia, which must have resolved to ≤ Grade 2
* Decreased ANC, which must have resolved to ≤ Grade 2
Have clinically significant cardiopulmonary disease
Have known myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to first dose of study treatment
Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to enrollment (≤56 days for hepatectomy, open thoracotomy, or major neurosurgery) or anticipation of need for major surgical procedure during the study
Serious, non-healing wound, ulcer, or bone fracture
Known to be positive for hepatitis B by surface antigen expression
Known to have active hepatitis C infection
* Exception for participants with a documented sustained virologic response of 12 weeks
Known to be positive for human immunodeficiency virus (HIV)
Subjects who are pregnant, breastfeeding, or planning a pregnancy
Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications
Have used strong CYP2C8 inhibitor within 5 half-lives of the inhibitor, or have used a strong CYP2C8 or CYP3A4 inducer within 5 days prior to first dose of study treatment
History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
* Exceptions are malignancies with a negligible risk of metastasis or death
Subjects with known active CNS metastasis
* Irradiated or resected lesions are permitted, provided the lesions are fully treated and inactive, subject is asymptomatic, and no steroids have been administered for at least 30 days
Clareo Health | Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer
