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Clinical Trial 18862

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT01969643

Phase: Phase I
Prinicipal Investigator: Heather Han

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Overview

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

Summary

This study is being done to find out what side effects (unwanted effects) are caused in participants with breast cancer who are given SGN-LIV1A (single therapy). This study will also look at other effects of SGN-LIV1A, including its effect on this type of cancer. This study is also being done to find out what side effects (unwanted effects) are caused in participants with HER2-positive breast cancer who are given SGN-LIV1A in combination with trastuzumab (combination therapy).

Objective

Primary Objectives: - To evaluate the safety and tolerability of SGN-LIV1A in patients with LIV-1-positive, incurable, unresectable, LA/MBC. - To identify the maximum tolerated dose (MTD) of SGN-LIV1A, if one exists among doses tested. - To evaluate the safety and tolerability of treatment with SGN-LIV1A given in combination with trastuzumab to patients with HER2-positive- and LIV-1-positive LA/MBC (Part B only). Secondary Objectives: - To assess the pharmacokinetics (PK) of SGN-LIV1A. - To assess the immunogenicity of SGN-LIV1A. - To assess the antitumor activity of SGN-LIV1A. Additional Objectives: - To assess exploratory biomarkers of SGN-LIV1A-mediated pharmacodynamic effects and to evaluate LIV-1 expression in tumor tissue. - To evaluate the LIV-1 expression-response relationship following treatment with SGN-LIV1A.

Treatments

Therapies

Medications

Herceptin (Trastuzumab); SGN-LIV1A (); Trastuzumab (); rhuMAb HER2 (Trastuzumab)

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: a) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or b) ER- 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; or c) Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting.
  • Positive for LIV-1 expression by central pathology review on archival or newly obtained tumor tissue biopsy. If patient has lesions that cannot be safely and/or adequately sampled, an exemption may be allowed.
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Must have completed treatment with chemotherapy, radiiotherapy, hormonal therapy, or other treatment with an investigational agent 2>/= weeks prior to first dose of study drug, unless disease progression is documented, and have recovered from any clinically significant toxicity associated with the treatment.
  • Must have completed treatment with a biologic agent or immunotherapy >/= 4 weeks prior to the first dose of study drug, unless disease progression is documented, and have recovered from any clinically significant toxicity associated with treatment. An exception to this requirement is treatment with denosumab, which is permitted on study.
  • Baseline laboratory tests as defined per protocol.
  • Females of child bearing potential must have a negative serum or urine pregnancy test result within 7 days prior to the first dose of SGN-LIV1A and must agree to use 2 effective contraceptive methods during the study and for an extended time after the last dose of study drug. Examples of effective contraceptive methods are outlined in the protocol.
  • Combination Arm: adequate heart function

  • Exclusion Criteria

  • Pre-existing neuropathy Grade 2 or higher
  • History of another primary invasive malignancy that has not been in remission for at least 3 years with the exception of carinoma in situ of the cervix, squamous or basal cell skin cancer, or thyroid cancer.
  • 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.
  • Any active Grade 3 or higher (per the NCI CTCAE v4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-LIV1A
  • Positive for hepatitis B by surface antigen expression, active hepatitis C infection (positive by polymerase chain reaction (PCR) or on antiviral therapy for hepatitis C within the last 6 months), or a known history of being seropositive for HIV
  • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to their first dose of SGN-LIV1A
  • Females who are breastfeeding
  • Known hypersensitivity to any excipient contained in the drug formulation of SGN-LIV1A.
  • Major surgery ≤3 weeks of study treatment.
  • Combination Arm: Known hypersensitivity to trastuzumab.
  • Prior treatment with SGN-LIV1A or prior treatment with an MMAE-containing therapy
  • Other serious or uncontrolled underlying medical condition that, in the opinion of the investigator, would impair the ability to receive or tolerate the planned treatment and follow-up; any psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the trial.

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