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Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer

This study is currently recruiting participants.
Verified November 2016 by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980341
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
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.
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
  Purpose

This is an open-label, three-part, non-randomized, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer.

The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study treatment until the end of the trial.


Condition Intervention Phase
Metastatic Breast Cancer Drug: U3-1402 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2, Multicenter, Non-randomized, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

Primary Outcome Measures:
  • Number of participants experiencing adverse events [ Time Frame: From signing of informed consent form (ICF) through 28 days after last dose, within about 6 months ]
    To investigate the safety of U3-1402 reporting on frequency and seriousness of treatment emergent adverse events.

  • Number of participants with tumor response throughout the study using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 [ Time Frame: From screening until disease progresses, within about 6 months ]
    Assessment of tumor response is conducted every 6 weeks in the first 24 weeks and thereafter every 12 weeks until progressive disease to evaluate the efficacy of U3-1402.


Secondary Outcome Measures:
  • Change in area under the serum concentration time curve (AUC) of U3-1402 [ Time Frame: From first dose to Cycle 8, within 24 weeks ]
    Area under curve at Cycle 1, Days 1, 2, 4, 8, 15; Cycle 2, Days 1, 8, 15; Cycle 3, Days 1, 2, 4, 8, 15; Cycle 4,6,8; Day 1

  • Change in the maximum plasma concentration (Cmax) of U3-1402 [ Time Frame: From first dose to Cycle 8, within 24 weeks ]
    Maximum plasma concentration at Cycle 1, Days 1, 2, 4, 8, 15; Cycle 2, Days 1, 8, 15; Cycle 3, Days 1, 2, 4, 8, 15; Cycle 4,6,8; Day 1

  • Change in the time to maximum plasma concentration (Tmax) of U3-1402 [ Time Frame: From first dose to Cycle 8, within 24 weeks ]
    Time of maximum plasma concentration at Cycle 1, Days 1, 2, 4, 8, 15; Cycle 2, Days 1, 8, 15; Cycle 3, Days 1, 2, 4, 8, 15; Cycle 4,6,8; Day 1

  • Change in the total anti-HER3 antibody from U3-1402 [ Time Frame: From first dose to Cycle 8, within 24 weeks ]
    Cycle 1, Days 1, 2, 4, 8, 15; Cycle 2, Days 1, 8, 15; Cycle 3, Days 1, 2, 4, 8, 15; Cycle 4,6,8; Day 1

  • Change in the MAAA-1181 level from U3-1402 [ Time Frame: From first dose to Cycle 8, within 24 weeks ]
    To determine the change in MAAA-1181 level from first dose to Cycle 8 at Cycle 1, Days 1, 2, 4, 8, 15; Cycle 2, Days 1, 8, 15; Cycle 3, Days 1, 2, 4, 8, 15; Cycle 4,6,8; Day 1


Estimated Enrollment: 80
Study Start Date: November 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation Part
The maximum tolerated dose is determined in the Dose Escalation Part by administering U3-1402 from 1.6 mg/kg to 9.7 mg/kg, administered via intravenous (IV) solution at 3-week intervals.
Drug: U3-1402
An investigational drug, not yet approved for marketing.
Other Name: Experimental drug
Experimental: Dose Finding Part
The recommended dose is determined in the Dose Finding Part by administering U3-1402 at different doses based on Dose Escalation Part results, administered via IV solution at 3-week intervals.
Drug: U3-1402
An investigational drug, not yet approved for marketing.
Other Name: Experimental drug
Experimental: Phase 2 Part
The safety and efficacy of the recommended dose is determined in the Phase 2 Part by administering U3-1402 at the recommended dose determined in the Dose Finding Part, administered via IV solution at 3-week intervals.
Drug: U3-1402
An investigational drug, not yet approved for marketing.
Other Name: Experimental drug

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Has a pathologically documented advanced/unresectable or metastatic breast cancer.
  2. Eastern Cooperative Oncology Group performance status of 0 or 1.
  3. Documented HER3-positive disease measured by immunohistochemistry (IHC) (IHC 2+ or 3+).
  4. Has been treated with standard treatment, or for which no standard treatment is available.
  5. Has an Eastern Cooperative Oncology Group Performance Status 0-1.
  6. Has Left Ventricular Ejection Fraction ≥ 50%.
  7. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Additional Inclusion Criteria for Dose Finding Part and Phase 2 Part

1. Has received 6 or fewer prior chemotherapy regimens including anthracyclines and taxanes.

Exclusion Criteria:

  1. Prior treatment with a HER3 antibody.
  2. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, DS-8201).
  3. Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious cardiac arrhythmia requiring treatment.
  4. Has a medical history of myocardial infarction or unstable angina.
  5. Has a corrected QT prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
  6. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period.
  7. Has cataracts, glaucoma, or increased intraocular pressure at baseline.
  Contacts and Locations
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): NCT02980341


Contacts
Contact: Hayao Ogawa, DL +81-3-5740-3792

Locations
Japan
National Cancer Center Hospital East Recruiting
Chiba, Japan, 277-8577
National Cancer Center Hospital Recruiting
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
  More Information

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02980341     History of Changes
Other Study ID Numbers: U31402-A-J101
JapicCTI-163401 ( Registry Identifier: JapicCTI )
First Submitted: November 28, 2016
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: November 2016

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Oncology
HER3
Antibody drug conjugate
Developmental Phase I/II

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases