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Antibody-Drug Conjugate

Patritumab Deruxtecan for Breast Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Daiichi Sankyo Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has progressed after receiving 1 to 2 prior chemotherapy regimens for advanced/unresectable or metastatic breast cancer.
Is 18 Years and older in the United States or 20 Years and older in Japan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights

Study Summary

This trial is testing a new drug for safety, tolerability, and efficacy in patients with a certain type of cancer. The number of patients and treatment cycles are not fixed, and subjects may continue the study treatment until the end of the trial if they continue to derive clinical benefit from the study treatment.

Who is the study for?
This trial is for adults with HER3-positive metastatic breast cancer who've had 2-6 prior chemo treatments, including a taxane. They must have an ECOG performance status of 0-1, measurable disease by RECIST criteria, and a heart ejection fraction ≥50%. Exclusions include previous HER3 antibody or certain ADC therapies, significant heart conditions or arrhythmias, QT prolongation, corneal diseases, and specific lung diseases.Check my eligibility
What is being tested?
The study tests U3-1402 (Patritumab Deruxtecan), which targets the HER3 receptor in advanced breast cancer. It's an open-label trial without fixed patient numbers or treatment cycles. Participants can continue treatment if they benefit from it unless they face unacceptable side effects or their disease progresses.See study design
What are the potential side effects?
While not explicitly listed here, similar drugs often cause side effects like fatigue, nausea, hair loss from chemotherapy components; potential cardiac issues due to stress on the heart; infusion reactions; and possibly lung problems given the exclusion criteria related to pulmonary health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have tried 1 or 2 chemotherapy treatments for advanced or metastatic breast cancer, but they did not work.
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You are at least 18 years old in the United States or at least 20 years old in Japan.
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You have been diagnosed with advanced or metastatic breast cancer that cannot be removed with surgery.
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You have a disease that doesn't get better with regular treatment, or you can't tolerate the standard treatment, or there's no more standard treatment available for your disease.
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You are able to perform daily activities without needing much help.
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You have a specific type of measurable disease according to certain medical guidelines.
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You have already received 2-6 rounds of chemotherapy for advanced or metastatic breast cancer, and at least one of these rounds included a medication called taxane.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants experiencing adverse events (AEs)
Number of participants with tumor response throughout the study using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Secondary outcome measures
Dose Escalation Part: Area under the serum concentration time curve (AUC) of U3-1402
Dose Escalation Part: Change in MAAA-1181 level from U3-1402
Dose Escalation Part: Change in Total anti-HER3 antibody from U3-1402
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose Finding PartExperimental Treatment1 Intervention
Participants receive 1 of 5 different U3-1402 dosing regimens, administered via IV solution at 2 or 3-week intervals at doses at or lower than those studied in the Dose Escalation Part.
Group II: Dose Expansion PartExperimental Treatment1 Intervention
Participants with HER3 high, HER2 negative, HR positive status receive 4.8 mg/kg or 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 low, HER2 negative, HR positive status receive 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 high, HER2 negative, HR negative status receive 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
Group III: Dose Escalation PartExperimental Treatment1 Intervention
Participants receive U3-1402 from 1.6 mg/kg to 9.6 mg/kg, administered via intravenous (IV) solution at 3-week intervals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patritumab Deruxtecan
2016
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
388 Previous Clinical Trials
409,327 Total Patients Enrolled
26 Trials studying Breast Cancer
17,627 Patients Enrolled for Breast Cancer
Daiichi Sankyo Co., Ltd.Lead Sponsor
115 Previous Clinical Trials
49,045 Total Patients Enrolled
4 Trials studying Breast Cancer
1,942 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
414,925 Total Patients Enrolled
28 Trials studying Breast Cancer
19,602 Patients Enrolled for Breast Cancer

Media Library

U3-1402 (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT02980341 — Phase 1 & 2
Breast Cancer Research Study Groups: Dose Escalation Part, Dose Finding Part, Dose Expansion Part
Breast Cancer Clinical Trial 2023: U3-1402 Highlights & Side Effects. Trial Name: NCT02980341 — Phase 1 & 2
U3-1402 (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02980341 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~22 spots leftby Mar 2025