← Back to Search

Monoclonal Antibodies

U3-1402 for Metastatic Breast Cancer

Phase 2
Recruiting
Research Sponsored by SCRI Development Innovations, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for at least 7 months following last dose
Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed ≥4 weeks prior to initiation of study treatment (2 weeks for patients who received palliative radiation therapy), there is no evidence of central nervous system disease progression on a scan or mild neurologic symptoms, and there is no requirement for chronic corticosteroid therapy for the treatment of brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective for patients with breast cancer that has spread.

Who is the study for?
This trial is for adults with advanced or metastatic breast cancer who have tried certain treatments without success. Eligible patients must not be pregnant, should agree to use two forms of contraception, and cannot have severe heart conditions or active infections like hepatitis or HIV. They also need to have at least one measurable tumor lesion and acceptable organ function.Check my eligibility
What is being tested?
The study tests U3-1402 (patritumab deruxtecan), an antibody drug conjugate, for safety and effectiveness in treating locally advanced or metastatic breast cancer. Participants will receive this experimental medication to see if it helps control their cancer better than current treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation of organs, infusion-related reactions which could occur during treatment administration, fatigue, digestive issues like nausea or diarrhea, blood disorders that can affect cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using two forms of birth control, including a barrier method, and will continue for 7 months after the last dose.
Select...
I had brain metastases treatment over 4 weeks ago, no worsening, mild symptoms, and don't need steroids.
Select...
My breast cancer is HER2-negative and I've received specific treatments.
Select...
I have triple-negative breast cancer and received 1-5 chemotherapy treatments for it in the metastatic stage.
Select...
My cancer is HER2-positive according to specific guidelines.
Select...
I have HR+ HER2- breast cancer and was treated with endocrine therapy and a CDK 4/6 inhibitor.
Select...
My breast cancer has spread beyond the initial site.
Select...
My organs are functioning well enough for treatment.
Select...
I am 18 years old or older and have signed the consent form.
Select...
I am willing to have biopsies before and during treatment, and my tumor can be biopsied.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or up to 33 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
Overall response rate (ORR) of single agent U3-1402 (patritumab deruxtecan) in participants with MBC
Rate of participants without disease progression at 6 month to determine six-months Progression Free survival (PFS-6) of single agent U3-1402 (patritumab deruxtecan) in participants with MBC
Secondary outcome measures
Clinical Benefit Rate (CBR) in participants with MBC
Incidence of participants with adverse events to assess the safety and tolerability of U3-1402 (patritumab deruxtecan) in participants with MBC
Median Duration of Response (DOR) in participants with MBC
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part ZExperimental Treatment1 Intervention
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z will enroll an additional 21 participants with HER2+ MBC.
Group II: Part BExperimental Treatment1 Intervention
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B will enroll 20 participants with metastatic hormone-receptor positive (HR+) HER2-negative cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
Group III: Part AExperimental Treatment1 Intervention
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies. (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). Up to 60 participants will be enrolled into this arm.

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
389 Previous Clinical Trials
409,795 Total Patients Enrolled
26 Trials studying Breast Cancer
17,627 Patients Enrolled for Breast Cancer
SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,442 Total Patients Enrolled
26 Trials studying Breast Cancer
2,464 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
415,133 Total Patients Enrolled
28 Trials studying Breast Cancer
19,602 Patients Enrolled for Breast Cancer

Media Library

U3-1402 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04699630 — Phase 2
Breast Cancer Research Study Groups: Part A, Part B, Part Z
Breast Cancer Clinical Trial 2023: U3-1402 Highlights & Side Effects. Trial Name: NCT04699630 — Phase 2
U3-1402 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04699630 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its seal of approval to U3-1402?

"Considering the Phase 2 status of U3-1402, our team has assigned it a safety rating of 2 due to there being evidence for its safety but no record yet of efficacy."

Answered by AI

Is this trial currently open to participants?

"Affirmative. According to data posted on clinicaltrials.gov, this medical study is actively recruiting as of now. After appearing online for the first time in May 2021, it was most recently updated in July 2022 and seeks 120 participants across 10 sites."

Answered by AI

Are there multiple locations where this investigation is taking place in the state?

"The trial is currently accepting patients from a variety of sites, such as City of Hope in Duarte, Washington University School of Medicine in Saint Louis, and Florida Cancer Specialists-South in Fort Myers. Additionally, there are 7 other available venues."

Answered by AI

What is the maximum number of participants allowed in this trial?

"This clinical trial necessitates 120 eligible patients to be involved in the study. Candidates can partake at either City of Hope situated in Duarte, California or Washington University School of Medicine located in Saint Louis, Missouri."

Answered by AI

What are the major goals of this research trial?

"Daiichi Sankyo, Inc., the clinical trial sponsor company, aims to measure Proportion of participants without disease progression at 6 month (PFS-6) rate with single agent U3-1402 in MBC patients. Furthermore, they are aiming to track Clinical Benefit Rate (CBR), PFS among HER2+ MBC after trastuzumab deruxtecan treatment and median PFS for all participants over a 33 months period. To determine CBR according to RECIST v 1.1 criteria CR is defined as disappearance of all target and non-target lesions; PR is ≥30% decrease in sum"

Answered by AI
~43 spots leftby Nov 2025