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A Safety Study of SGN-LIV1A in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01969643
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HER2 Positive Breast Neoplasms Hormone Receptor Positive Breast Neoplasms Triple Negative Breast Neoplasms HER2 Mutations Breast Neoplasms Drug: ladiratuzumab vedotin Drug: Trastuzumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer
Actual Study Start Date : October 22, 2013
Actual Primary Completion Date : February 4, 2023
Actual Study Completion Date : February 4, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]
    To be summarized using descriptive statistics.

  3. Incidence of dose-limiting toxicity (DLT) [ Time Frame: Through 3 weeks after first dose ]

Secondary Outcome Measures :
  1. Blood concentrations of LV and metabolites [ Time Frame: Through 3 weeks after dosing; up to approximately 2 years ]
  2. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]
  3. 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.

  4. 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).

  5. 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).

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969643


Locations
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Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Brandon Croft, PharmD Seagen Inc.
Study Director: Zejing Wang, MD, PhD Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT01969643    
Other Study ID Numbers: SGNLVA-001
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
Monomethyl auristatin E
Antibody-drug conjugate
Drug therapy
Metastatic
LIV-1 protein, human
 Trastuzumab
Ladiratuzumab vedotin
hLIV22-vcMMAE
Seattle Genetics
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Trastuzumab
 SGN-LIV1A
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs