ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    BTRC4017A
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03448042
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

February 20, 2018
February 27, 2018
September 24, 2018
June 6, 2018
May 31, 2024   (Final data collection date for primary outcome measure)
Percentage of Participants with Adverse Events [ Time Frame: From baseline through end of study (approximately 78 months) ]
Same as current
Complete list of historical versions of study NCT03448042 on ClinicalTrials.gov Archive Site
  • Serum Concentration of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  • Area Under the Serum Concentration vs. Time Curve (AUC) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  • Maximum Observed Serum Concentration (Cmax) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  • Minimum Observed Serum Concentration (Cmin) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  • Clearance (CL) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  • Volume of Distribution at Steady State (Vss) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  • Objective Response (OR) as Determined by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) [ Time Frame: Baseline through the end of study (approximately 78 months) ]
  • Duration of Response (DOR) [ Time Frame: From the first occurrence of a documented objective response to first documented disease progression or death from any cause, through the end of study (approximately 78 months) ]
  • Anti-Drug Antibody (ADA) Levels of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
Same as current
Not Provided
Not Provided
 
A Phase I Study of BTRC4017A in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of BTRC4017A Administered Intravenously in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors
Drug: BTRC4017A
BTRC4017A will be administered via IV infusion from until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
  • Experimental: Dose Escalation
    Participants will be assigned sequentially to escalating doses of BTRC4017A, up to the maximum tolerated dose (MTD).
    Intervention: Drug: BTRC4017A
  • Experimental: Dose Expansion
    Participants will receive BTRC4017A based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
    Intervention: Drug: BTRC4017A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
449
Same as current
May 31, 2024
May 31, 2024   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Reference Study ID Number: GO40311 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Korea, Republic of,   United States
 
 
NCT03448042
GO40311
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP