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

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ClinicalTrials.gov Identifier: NCT03448042
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: BTRC4017A Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 449 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Arm Intervention/treatment
Experimental: Dose Escalation
Participants will be assigned sequentially to escalating doses of BTRC4017A, up to the maximum tolerated dose (MTD).
Drug: BTRC4017A
BTRC4017A will be administered via IV infusion from until disease progression, intolerable toxicity, or any other discontinuation criteria are met.

Experimental: Dose Expansion
Participants will receive BTRC4017A based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
Drug: BTRC4017A
BTRC4017A will be administered via IV infusion from until disease progression, intolerable toxicity, or any other discontinuation criteria are met.




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: From baseline through end of study (approximately 78 months) ]

Secondary Outcome Measures :
  1. Serum Concentration of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  2. 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. ]
  3. Maximum Observed Serum Concentration (Cmax) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  4. Minimum Observed Serum Concentration (Cmin) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  5. Clearance (CL) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  6. Volume of Distribution at Steady State (Vss) of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]
  7. 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) ]
  8. 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) ]
  9. Anti-Drug Antibody (ADA) Levels of BTRC4017A [ Time Frame: At predefined intervals from Cycle 1, Day 1, up to approximately 1 year. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448042


Contacts
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

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
United States, Missouri
Washington University; Wash Uni. Sch. Of Med Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Australia, Victoria
Peter MacCallum Cancer Centre; Medical Oncology Not yet recruiting
Melbourne, Victoria, Australia, 3000
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03448042     History of Changes
Other Study ID Numbers: GO40311
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No