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

Description

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.

Study Start Date

March, 05 2018

Estimated Completion Date

May 2024

Interventions

  • Drug: BTRC4017A

Study ID

Genentech, Inc. -- GO40311

Status

Recruiting

Trial ID

NCT03448042

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

449

Sponsor

Genentech, Inc.

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 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
  • Gender

    All

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (4)

    Study Location Distance Name Phone Email
    Yale University - New Haven, Connecticut 18.0 miles None None None
    Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles None None None
    Sarah Cannon Research Institute - Nashville, Tennessee 810.5 miles None None None
    MD Anderson Cancer Center - Houston, Texas 1,475.7 miles None None None

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