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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01969643
Recruitment Status : Recruiting
First Posted : October 25, 2013
Last Update Posted : December 9, 2020
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 SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given alone or in combination with trastuzumab.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: SGN-LIV1A Drug: Trastuzumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 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
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : March 31, 2022

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: SGN-LIV1A Dose Escalation Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV)
Experimental: SGN-LIV1A + Trastuzumab Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV)

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: SGN-LIV1A
SGN-LIV1A will be given at the recommended dose (at or below the monotherapy MTD determined in the SGN-LIV1A dose escalation arm).
 Drug: SGN-LIV1A
SGN-LIV1A will be given by intravenous infusion (into the vein; IV)


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 ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]

Secondary Outcome Measures :
  1. Blood concentrations of SGN-LIV1A 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.
  • Parts A, B, C, and D: Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
  • Part E: Archival baseline tumor sample is required; a fresh biopsy sample may be submitted in place of an archival sample if medically feasible.
  • 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. Part E: Known or suspected cerebral/meningeal metastasis that has not been definitively treated.
  • Prior treatment with SGN-LIV1A 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


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Phillip Garfin, MD 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: December 9, 2020
Last Verified: December 2020
Keywords provided by Seagen Inc.:
Breast cancer
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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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents