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.
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
Interventions
Drug | Synonyms | Arms |
---|
BTRC4017A | | Dose 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
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Participants will be assigned sequentially to escalating doses of BTRC4017A, up to the maximum tolerated dose (MTD). | |
Dose Expansion | Experimental | Participants will receive BTRC4017A based on the MTD or maximum allowed dose (MAD) identified during dose escalation. | |
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
August 5, 2021