Clinical Trials /

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

NCT03448042

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Breast Carcinoma
  • Gastric Adenocarcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase I Study of BTRC4017A in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: GO40311
  • NCT ID: NCT03448042

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
BTRC4017ADose Escalation

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalParticipants will be assigned sequentially to escalating doses of BTRC4017A, up to the maximum tolerated dose (MTD).
  • BTRC4017A
Dose ExpansionExperimentalParticipants will receive BTRC4017A based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
  • BTRC4017A

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of Participants with Adverse Events
Time Frame:From baseline through end of study (approximately 78 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Serum Concentration of BTRC4017A
Time Frame:At predefined intervals from Cycle 1, Day 1, up to approximately 1 year.
Safety Issue:
Description:
Measure: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.
Safety Issue:
Description:
Measure:Maximum Observed Serum Concentration (Cmax) of BTRC4017A
Time Frame:At predefined intervals from Cycle 1, Day 1, up to approximately 1 year.
Safety Issue:
Description:
Measure:Minimum Observed Serum Concentration (Cmin) of BTRC4017A
Time Frame:At predefined intervals from Cycle 1, Day 1, up to approximately 1 year.
Safety Issue:
Description:
Measure:Clearance (CL) of BTRC4017A
Time Frame:At predefined intervals from Cycle 1, Day 1, up to approximately 1 year.
Safety Issue:
Description:
Measure:Volume of Distribution at Steady State (Vss) of BTRC4017A
Time Frame:At predefined intervals from Cycle 1, Day 1, up to approximately 1 year.
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Anti-Drug Antibody (ADA) Levels of BTRC4017A
Time Frame:At predefined intervals from Cycle 1, Day 1, up to approximately 1 year.
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genentech, Inc.

Last Updated

May 3, 2018