Your session is about to expire
← Back to Search
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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
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 moreTrial 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 Sankyo Co., Ltd.Lead Sponsor
115 Previous Clinical Trials
48,902 Total Patients Enrolled
4 Trials studying Breast Cancer
1,942 Patients Enrolled for Breast Cancer
Daiichi SankyoIndustry Sponsor
393 Previous Clinical Trials
416,117 Total Patients Enrolled
26 Trials studying Breast Cancer
17,627 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
419,974 Total Patients Enrolled
28 Trials studying Breast Cancer
19,602 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with advanced or metastatic breast cancer that cannot be removed with surgery.Your disease has been confirmed to be HER3-positive through a specific test called immunohistochemistry.You are able to perform daily activities without needing much help.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.You have received treatment with a HER3 antibody before.You have received treatment with a specific type of medication called an antibody-drug conjugate that contains a certain kind of drug.You have a history of serious heart problems that have caused symptoms or required treatment.You have a history of heart attack or unstable chest pain.Your heart's electrical activity is too slow, which can cause problems.You have a serious eye condition affecting the cornea.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.You have a history of serious lung diseases or are suspected to have them based on screening tests.You have already been treated with a drug similar to govitecan (such as IMMU-132).You have been confirmed to have hormone receptor-negative and HER2-negative breast cancer based on specific testing guidelines.You have a specific type of measurable disease according to certain medical guidelines.You have tried 1 or 2 chemotherapy treatments for advanced or metastatic breast cancer, but they did not work.Your heart's pumping function is normal.You have certain types of breast cancer that are positive for hormone receptors but negative for HER2.You are at least 18 years old in the United States or at least 20 years old in Japan.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Part
- Group 2: Dose Escalation Part
- Group 3: Dose Finding Part
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger