A Safety Study of SGN-LIV1A in Breast Cancer Patients

Phase 1

Completed

• Conditions: HER2 Positive Breast Neoplasms; Hormone Receptor Positive Breast Neoplasms; Triple Negative Breast Neoplasms; HER2 Mutations Breast Neoplasms
• Interventions: Drug: ladiratuzumab vedotin; Drug: Trastuzumab

• Registration Number: NCT01969643
• Lead Sponsor: Seagen Inc.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Study Start: 2013-10-22
• Study First Posted: 2013-10-25
• Primary Completion: 2023-02-04
• Study Completion: 2023-02-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 290

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LV + Trastuzumab	Trastuzumab	-
LV Dose Escalation	ladiratuzumab vedotin	-
LV + Trastuzumab	ladiratuzumab vedotin	-
LV Monotherapy	ladiratuzumab vedotin	LV will be given at the recommended dose (at or below the monotherapy MTD determined in the LV dose escalation arm).

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	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.
Incidence of laboratory abnormalities	Through 1 month following last dose; up to approximately 2 years	To be summarized using descriptive statistics.
Incidence of dose-limiting toxicity (DLT)	Through 3 weeks after first dose

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	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.
Progression-free survival (PFS)	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).
PFS relative to prior therapy	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.
Blood concentrations of LV and metabolites	Through 3 weeks after dosing; up to approximately 2 years
Duration of response (DOR)	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).
Incidence of antitherapeutic antibodies	Through 1 month following last dose; up to approximately 2 years
Overall survival (OS)	Up to approximately 8 years	OS is defined as the time from start of study treatment to date of death due to any cause.

Trial Locations

Locations (38)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Northwest Medical Specialties; 🇺🇸 Puyallup, Washington, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Case Western Reserve University / University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Pinnacle Oncology Hematology; 🇺🇸 Scottsdale, Arizona, United States

UCLA Medical Center / David Geffen School of Medicine; 🇺🇸 Santa Monica, California, United States

Piedmont Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Washington University in St Louis; 🇺🇸 Saint Louis, Missouri, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Cancer Care Centers of South Texas - HOAST/Texas Oncology; 🇺🇸 New Braunfels, Texas, United States

Texas Oncology - Baylor Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

UC San Diego / Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute; 🇺🇸 Los Angeles, California, United States

The Whittingham Cancer Center / Norwalk Hospital; 🇺🇸 Norwalk, Connecticut, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of New Mexico Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Poudre Valley Health System (PVHS); 🇺🇸 Fort Collins, Colorado, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Rocky Mountain Cancer Centers - Aurora; 🇺🇸 Aurora, Colorado, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Louisiana State University Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Karmanos Cancer Institute / Wayne State University; 🇺🇸 Detroit, Michigan, United States

Allina Health Cancer Institute; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Tennessee Oncology-Nashville/Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Wake Forest Baptist Medical Center / Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Seattle Cancer Care Alliance / University of Washington; 🇺🇸 Seattle, Washington, United States