HER2 Positive Breast NeoplasmsPhase 1NCT01969643
A Safety Study of SGN-LIV1A in Breast Cancer Patients
A Phase 1 study testing ladiratuzumab vedotin and Trastuzumab in people with HER2 Positive Breast Neoplasms and Hormone Receptor Positive Breast Neoplasms, run by Seagen Inc. at 38 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms
- What is being tested?
- ladiratuzumab vedotin and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 38 sitesUnited States
- Study dates
- 22 Oct 2013to 4 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
Piedmont Cancer Institute
Atlanta, Georgia, 30309
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012
University of Maryland
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Medical Center
Chicago, Illinois, 60637
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Cleveland Clinic
Cleveland, Ohio, 44195
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, 75246
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
Poudre Valley Health System (PVHS)
Fort Collins, Colorado, 80528
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
UC San Diego / Moores Cancer Center
La Jolla, California, 92093
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55455
West Virginia University
Morgantown, West Virginia, 26506
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Cancer Care Centers of South Texas - HOAST/Texas Oncology
New Braunfels, Texas, 78130
Yale Cancer Center
New Haven, Connecticut, 06520
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medicine
New York, New York, 10065
The Whittingham Cancer Center / Norwalk Hospital
Norwalk, Connecticut, 06856
Oregon Health and Science University
Portland, Oregon, 97239
Northwest Medical Specialties
Puyallup, Washington, 98373
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of California at San Francisco
San Francisco, California, 94134
UCLA Medical Center / David Geffen School of Medicine
Santa Monica, California, 90404
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258
Swedish Cancer Institute
Seattle, Washington, 98104
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109
Washington University in St Louis
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Wake Forest Baptist Medical Center / Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
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
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.
- Conditions
- HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms
- Being tested
- ladiratuzumab vedotin, Trastuzumab
- Keywords
- Monomethyl auristatin E, Antibody-drug conjugate, Drug therapy, Metastatic, LIV-1 protein, human, Trastuzumab, Ladiratuzumab vedotin, hLIV22-vcMMAE, Seattle Genetics
- Medical subject headings
- Triple Negative Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ladiratuzumab vedotinDrug
Also called LV, SGN-LIV1A
LV will be given into the vein (IV; intravenously)
TrastuzumabDrug
Also called Herceptin
Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| LV Dose Escalation | Experimental | Not described Receives: Drug: ladiratuzumab vedotin |
| LV + Trastuzumab | Experimental | Not described Receives: Drug: ladiratuzumab vedotin; Drug: Trastuzumab |
| LV Monotherapy | Experimental | LV will be given at the recommended dose (at or below the monotherapy MTD determined in the LV dose escalation arm). Receives: Drug: ladiratuzumab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
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.
Measured: Through 1 month following last dose; up to approximately 2 years
Incidence of laboratory abnormalities
To be summarized using descriptive statistics.
Measured: Through 1 month following last dose; up to approximately 2 years
Incidence of dose-limiting toxicity (DLT)
Measured: Through 3 weeks after first dose
Secondary outcomes (7)
Blood concentrations of LV and metabolites
Measured: Through 3 weeks after dosing; up to approximately 2 years
Incidence of antitherapeutic antibodies
Measured: Through 1 month following last dose; up to approximately 2 years
Objective response rate (ORR)
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.
Measured: Through 1 month following last dose; up to approximately 2 years
Duration of response (DOR)
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).
Measured: Up to approximately 3 years
Progression-free survival (PFS)
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).
Measured: Up to approximately 8 years
Overall survival (OS)
OS is defined as the time from start of study treatment to date of death due to any cause.
Measured: Up to approximately 8 years
PFS relative to prior therapy
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.
Measured: Up to approximately 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study start22 Oct 2013
- Primary completion4 Feb 2023
- Study completion4 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Positive Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brandon Croft, PharmD, Study director, Seagen Inc.Zejing Wang, MD, PhD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969643
- Sponsor's protocol ID
- SGNLVA-001
- Status last verified
- Mar 2023
- First submitted
- 21 Oct 2013
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01969643
- Acronym / sponsor ID
- SGNLVA-001
- Conditions
- HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms
- Keywords
- Monomethyl auristatin E, Antibody-drug conjugate, Drug therapy, Metastatic, LIV-1 protein, human, Trastuzumab, Ladiratuzumab vedotin, hLIV22-vcMMAE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2013 (actual)
- Primary completion
- 4 Feb 2023 (actual)
- Study completion
- 4 Feb 2023 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LV Dose Escalation | Experimental | Drug: ladiratuzumab vedotin |
| LV + Trastuzumab | Experimental | Drug: ladiratuzumab vedotin, Drug: Trastuzumab |
| LV Monotherapy | Experimental | Drug: ladiratuzumab vedotinLV will be given at the recommended dose (at or below the monotherapy MTD determined in the LV dose escalation arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
- One of the following:
- Part F: All of the following:
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ladiratuzumab vedotinAlso: LV, SGN-LIV1ALV will be given into the vein (IV; intravenously) | Drug | LV + Trastuzumab, LV Dose Escalation, LV Monotherapy |
| TrastuzumabAlso: HerceptinTrastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg) | Drug | LV + Trastuzumab |
Primary outcome
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.
Incidence of laboratory abnormalities
Time frame: Through 1 month following last dose; up to approximately 2 years
To be summarized using descriptive statistics.
Incidence of dose-limiting toxicity (DLT)
Time frame: Through 3 weeks after first dose
7 secondary outcomes
Blood concentrations of LV and metabolites
Time frame: Through 3 weeks after dosing; up to approximately 2 years
Incidence of antitherapeutic antibodies
Time frame: Through 1 month following last dose; up to approximately 2 years
Objective response rate (ORR)
Time frame: Through 1 month following last dose; up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
Time frame: Up to approximately 8 years
Overall survival (OS)
Time frame: Up to approximately 8 years
PFS relative to prior therapy
Time frame: Up to approximately 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon Croft, PharmD study director
Seagen Inc.
Zejing Wang, MD, PhD study director
Seagen Inc.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ladiratuzumab vedotin and Trastuzumab in people with HER2 Positive Breast Neoplasms and Hormone Receptor Positive Breast Neoplasms, run by Seagen Inc. at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Through 1 month following last dose; up to approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.