Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: A Phase I Study of BTRC4017A in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Summary: This study will evaluate the safety, tolerability, and pharmacokinetics of BTRC4017A in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.


Eligibility: Inclusion Criteria
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  -  Life expectancy of at least 12 weeks
  -  Adequate hematologic and end-organ function
  -  Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade </=1 prior to study entry
  -  Left Ventricular Ejection Fraction (LVEF) >/=50%
  HER2-Expressing Breast Cancer-Specific Inclusion Criteria
  -  Locally tested, Human Epidermal Growth Factor Receptor 2 (HER2)-expressing BC
  -  Locally advanced or metastatic BC that has relapsed or is refractory to established therapies
  HER2-Expressing Gastric/Gastroesophageal (GEJ) Cancer-Specific Inclusion Criteria
  -  Adenocarcinoma of the stomach or GEJ with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy
  -  HER2-expressing tumor (primary tumor or metastasis) as assessed by local lab testing
  -  HER2-positive gastric/GEJ cancer must have received prior trastuzumab, cisplatin (or carboplatin or oxaliplatin or investigational platinum agent) and 5-fluorouracil (5-FU)/capecitabine
  HER2-Positive Solid Tumor Specific Inclusion Criteria
  -  HER2-positive tumor (primary tumor or metastasis) as assessed by local (non-central) laboratory testing
  -  Locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care; or for whom a clinical trial of an investigational agent is considered an acceptable treatment option
  Exclusion Criteria
  -  Pregnant or breastfeeding, or intending to become pregnant during the study or within 140 days after the last dose of BTRC4017A
  -  Significant cardiopulmonary dysfunction
  -  Known clinically significant liver disease
  -  Positive for acute or chronic Hepatitis B virus (HBV) infection
  -  Acute or chronic Hepatitis C virus (HCV) infection
  -  Human Immunodeficiency Virus (HIV) seropositivity
  -  Poorly controlled Type 2 diabetes mellitus
  -  History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
  -  Current treatment with medications that are well known to prolong the Q-wave/T-wave (QT) interval
  -  Known clinically significant liver disease
  -  Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)
  -  Leptomeningeal disease
  -  Spinal cord compression that has not definitively treated with surgery and/or radiation
  -  History of autoimmune disease
  -  Prior allogeneic stem cell or solid organ transplantation

Relevance to patient case: possibly relevant