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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:November 2016
End Date:December 2020
Contact:Daiichi Sankyo Contact for Clinical Trial Information
Email:dsclinicaltrial@daiichisankyo.co.jp
Phone:+81-3-6225-1111(M-F 9-5 JST)

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Phase 1/2, Multicenter, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer

This is an open-label, three-part, 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.


Inclusion Criteria:

1. Is 18 Years and older in the United States or 20 Years and older in Japan

2. Has a pathologically documented advanced/unresectable or metastatic breast cancer

3. Documented HER3-positive disease measured by immunohistochemistry (IHC)

4. Has disease that is refractory to or intolerable with standard treatment, or for which
standard treatment no longer 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 Dose Expansion Part:

8. Has received 2-6 prior chemotherapy regimens for breast cancer, at least 2 of which
were administered for treatment of advanced/unresectable or metastatic disease. At
least 1 prior chemotherapeutic regimen must have included a taxane, administered in
the neoadjuvant, adjuvant, or advanced setting.

Additional Inclusion Criteria for Dose Expansion Part Only:

9. Is able to submit a fresh tumor biopsy sample prior to starting study treatment if not
already submitted for HER3 expression

10. Has documented HER2 negative expression according to American Society of Clinical
Oncology - College of American Pathologists (ASCO-CAP) guidelines

11. Has documented hormone (estrogen and/or progesterone) receptor (HR)-positive disease

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 clinically significant corneal disease
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Newnan, Georgia 30265
Phone: 770-400-6633
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-2100
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-3339
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Phone: 718-405-8523
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Dallas, Texas 75246
Phone: 214-370-1240
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Phone: 214-648-7042
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San Antonio, Texas 78229
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