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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02980341
Other study ID # U31402-A-J101
Secondary ID JapicCTI-163401
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date November 28, 2016
Est. completion date September 7, 2023

Study information

Verified date December 2023
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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), unacceptable toxicity, or death may continue the study treatment until the end of the trial.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date September 7, 2023
Est. primary completion date August 16, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. (With exception of Dose Expansion Part TNBC cohort. See additional inclusion criteria for Dose Expansion Part TNBC cohort.) 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 hormone (estrogen and/or progesterone) receptor (HR)-positive and HER2 negative expression according to American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines. (With exception of Dose Expansion Part TNBC cohort. See additional inclusion criteria for Dose Expansion Part TNBC cohort.) Additional Inclusion Criteria for Dose Expansion Part TNBC cohort Only: 11. Has documented hormone (estrogen and progesterone) receptor (HR)-negative and HER2 negative expression according to American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines 12. Has progressed after receiving 1 to 2 prior chemotherapy regimens for advanced/unresectable or metastatic breast cancer. 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 radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period 7. Has clinically significant corneal disease Additional Exclusion Criteria for Dose Expansion Part: 8. Prior treatment with an govitecan derivative (eg, IMMU-132).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Patritumab Deruxtecan
U3-1402 consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a)

Locations

Country Name City State
Japan National Cancer Center Hospital East Chiba
Japan Fukushima Medical University Hospital Fukushima
Japan Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital Hiroshima
Japan Hakuaikai Social Medical Corporation Sagara Hospital Kagoshima
Japan Kanagawa Cancer Center Kanagawa
Japan Kumamoto University Hospital Kumamoto
Japan Aichi Cancer Center Hospital Nagoya
Japan Nagoya City University Hospital Nagoya
Japan Kindai University Hospital Osaka
Japan National Hospital Organization Osaka National Hospital Osaka
Japan Osaka International Cancer Institute Osaka
Japan Saitama Cancer Center Saitama
Japan Saitama Medical University International Medical Center Saitama
Japan National Hospital Organization Hokkaido Cancer Center Sapporo-Shi Hokkaido
Japan National Cancer Center Hospital Tokyo
Japan The Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Albert Einstein College of Medicine Bronx New York
United States Northwestern University Chicago Illinois
United States Texas Oncology, P.A. Dallas Texas
United States UT Southwestern Medical Center Dallas Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Memorial Sloan Kettering Cancer Center New York New York
United States Southeastern Regional Medical Center Newnan Georgia
United States Mays Cancer Center San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
Daiichi Sankyo Co., Ltd. Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants experiencing adverse events (AEs) AEs will be collected systematically from signing of the informed consent form (ICF) through 28 days after last dose within about 6 months
Primary Number of participants with tumor response throughout the study using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 From screening until disease progresses, within about 6 months
Secondary Dose Escalation Part: Area under the serum concentration time curve (AUC) of U3-1402 Samples are obtained for all secondary outcome measures in the Dose Escalation Part at Cycle 1: Days 1, 2, 4, 8, 15; Cycle 2: Days 1, 8, 15; Cycle 3: Days 1, 2, 4, 8, 15; Cycles 4, 6, 8: Day 1 Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)
Secondary Dose Finding Part: AUC of U3-1402 Samples are obtained for all secondary outcome measures in the Dose Finding Part for the following categories:
Cohorts 1 and 2: at Cycle 1: Days 1, 2, 4, 8, 15; Cycle 2: Day 1; Cycle 3: Days 1, 8, 15; Cycles 4, 5, 6, 8: Day 1
Cohort 3: at Cycles 1, 2, 3: Days 1, 8, 15; Cycles 4, 5, 6, 8: Day 1
Cohorts 4 and 5: at Cycle 1: Days 1, 4, 8; Cycle 2: Day 1; Cycle 3: Days 1, 4, 8; Cycle 4: Days 1, 8, 15; Cycles 5, 6, 8: Day 1
Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)
Secondary Dose Expansion Part: AUC of U3-1402 Samples are obtained for all secondary outcome measures in the Dose Expansion Part at Cycle 1, Days 1, 2, 4, 8, 15; Cycle 2, Day 1; Cycle 3, Days 1, 8, 15; Cycles 4, 6, 8; Day 1 Cycle 1, Day 1 to Cycle 8, Day 1 (148 days)
Secondary Dose Escalation Part: Maximum plasma concentration (Cmax) of U3-1402 within 148 days
Secondary Dose Finding Part: Cmax of U3-1402 within 148 days
Secondary Dose Expansion Part: Cmax of U3-1402 within 148 days
Secondary Dose Escalation Part: Time to maximum plasma concentration (Tmax) of U3-1402 within 148 days
Secondary Dose Finding Part: Tmax of U3-1402 within 148 days
Secondary Dose Expansion Part: Tmax of U3-1402 within 148 days
Secondary Dose Escalation Part: Change in Total anti-HER3 antibody from U3-1402 Baseline, 6 months
Secondary Dose Finding Part: Change in Total anti-HER3 antibody from U3-1402 Baseline, 6 months
Secondary Dose Expansion Part: Change in Total anti-HER3 antibody from U3-1402 Baseline, 6 months
Secondary Dose Escalation Part: Change in MAAA-1181 level from U3-1402 within 148 days
Secondary Dose Finding Part: Change in MAAA-1181 level from U3-1402 within 148 days
Secondary Dose Expansion Part: Change in MAAA-1181 level from U3-1402 within 148 days
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