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Completed

NCT Number: NCT01969643

A Safety Study of SGN-LIV1A in Breast Cancer Patients

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.

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Key information

Conditions

HER2 Positive Breast Neoplasms Breast Diseases Breast Neoplasms HER2 Mutations Breast Neoplasms Hormone Receptor Positive Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ladiratuzumab vedotin

Drug

LV will be given into the vein (IV; intravenously)

Other names: LV, SGN-LIV1A

Trastuzumab

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2013
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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