A Safety Study of SGN-LIV1A in Breast Cancer Patients

March 3, 2023 updated by: Seagen Inc.

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer

This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Pinnacle Oncology Hematology
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego / Moores Cancer Center
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
      • San Francisco, California, United States, 94134
        • University of California at San Francisco
      • Santa Monica, California, United States, 90404
        • UCLA Medical Center / David Geffen School of Medicine
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers - Aurora
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Health System (PVHS)
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center
      • Norwalk, Connecticut, United States, 06856
        • The Whittingham Cancer Center / Norwalk Hospital
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute / Wayne State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health Cancer institute
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St Louis
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Cancer Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center / Wake Forest University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University / University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology-Nashville/Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Sammons Cancer Center
      • New Braunfels, Texas, United States, 78130
        • Cancer Care Centers of South Texas - HOAST/Texas Oncology
    • Washington
      • Puyallup, Washington, United States, 98373
        • Northwest Medical Specialties
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance / University of Washington
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)

  • One of the following:

    • Part A: Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);
    • Part B: Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
    • Part C: Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
    • Part D and Part E (dose-expansion cohort): Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
    • Part E: HR+(ER-positive and/or PR-positive)/HER2-negative disease who are chemotherapy-eligible and not considered a candidate for further hormonal therapy. Must have received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the LA/MBC setting.

  • Part F: All of the following:

    • Triple negative breast cancer
    • No prior cytotoxic chemotherapy for unresectable locally advanced or metastatic stage disease
    • Tumor tissue PD-L1 expression CPS <10 expression
  • Parts A, B, C, and D: Newly obtained or archived tumor tissue biopsy, must be collected for central pathology determination of LIV-1 expression
  • Parts E and F: Archival or fresh baseline tumor sample is required.
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Combination Arm: adequate heart function

Exclusion Criteria:

  • Pre-existing neuropathy Grade 2 or higher
  • Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying malignancy and has not been definitively treated. Parts E and F: Known or suspected cerebral/meningeal metastasis that has not been definitively treated.
  • Prior treatment with LV or prior treatment with an MMAE-containing therapy
  • Combination Arm: hypersensitivity to trastuzumab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LV Dose Escalation
Drug: ladiratuzumab vedotin
LV will be given into the vein (IV; intravenously)
Other Names:
  • LV
  • SGN-LIV1A
Experimental: LV + Trastuzumab
Drug: ladiratuzumab vedotin
LV will be given into the vein (IV; intravenously)
Other Names:
  • LV
  • SGN-LIV1A
Drug: Trastuzumab
Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
Other Names:
  • Herceptin
Experimental: LV Monotherapy
LV will be given at the recommended dose (at or below the monotherapy MTD determined in the LV dose escalation arm).
Drug: ladiratuzumab vedotin
LV will be given into the vein (IV; intravenously)
Other Names:
  • LV
  • SGN-LIV1A

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Through 1 month following last dose; up to approximately 2 years
An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through 1 month following last dose; up to approximately 2 years
Incidence of laboratory abnormalities
Time Frame: Through 1 month following last dose; up to approximately 2 years
To be summarized using descriptive statistics.
Through 1 month following last dose; up to approximately 2 years
Incidence of dose-limiting toxicity (DLT)
Time Frame: Through 3 weeks after first dose
Through 3 weeks after first dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood concentrations of LV and metabolites
Time Frame: Through 3 weeks after dosing; up to approximately 2 years
Through 3 weeks after dosing; up to approximately 2 years
Incidence of antitherapeutic antibodies
Time Frame: Through 1 month following last dose; up to approximately 2 years
Through 1 month following last dose; up to approximately 2 years
Objective response rate (ORR)
Time Frame: Through 1 month following last dose; up to approximately 2 years
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.
Through 1 month following last dose; up to approximately 2 years
Duration of response (DOR)
Time Frame: Up to approximately 3 years
DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (clinical progression or progressive disease (PD) per RECIST v1.1).
Up to approximately 3 years
Progression-free survival (PFS)
Time Frame: Up to approximately 8 years
PFS is defined as the time from start of study treatment to first documentation of tumor progression (clinical progression or PD per RECIST v1.1).
Up to approximately 8 years
Overall survival (OS)
Time Frame: Up to approximately 8 years
OS is defined as the time from start of study treatment to date of death due to any cause.
Up to approximately 8 years
PFS relative to prior therapy
Time Frame: Up to approximately 8 years
The PFS ratio is defined for each subject as the ratio of the current PFS and the PFS achieved on their most recent therapy where they experienced progression.
Up to approximately 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seagen Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Brandon Croft, PharmD, Seagen Inc.
  • Study Director: Zejing Wang, MD, PhD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGNLVA-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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