Breast Cancer Triple NegativePhase 1IMGN853NCT03045393
Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC
A Phase 1 study testing Mirvetuximab Soravtansine (IMGN853) in people with Breast Cancer Triple Negative, run by Duke University at 1 site in United States.
Trial summary
The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects the amount and activity of folate receptor alpha proteins in tumor cells of patients who have completed standard neoadjuvant treatment and are scheduled to have their tumors surgically removed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Triple Negative
- What is being tested?
- Mirvetuximab Soravtansine (IMGN853)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2017to 28 Feb 2018
- 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
- Written informed consent and HIPAA authorization for release of personal health information.
- Must have operable tumor ≥ 1cm determined by and obtained less than 9 weeks after completion of standard NAC
- Must be able to meet study schedule: 2 doses of mirvetuximab soravtansine administered 3 weeks apart and surgery within 9 weeks of last dose of NAC.
- Willing to undergo biopsy for research purposes only (before and after), and to allow surgical tissue sample from surgery to be used for research purposes
- May have symptoms however must be ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work)
- Demonstrate adequate organ function through labs
- Females of childbearing years must have a negative serum pregnancy test within 48 hours prior to dose 1 mirvetuximab soravtansine. NOTE: Sexually mature females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
- Females of childbearing potential must be willing to abstain from heterosexual activity or to use two effective methods of contraception from the time of informed consent until 4 months after the last dose of mirvetuximab soravtansine
Who cannot join
- Pregnant or breastfeeding, or plan to be pregnant within projected duration of the trial. (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has a known additional malignancy that is active and/or progressive requiring treatment within 3 years of first dose.
- Prior treatment with mirvetuximab soravtansine
- Treatment with any investigational drug within 6 weeks of first clinical dose
- Subjects with > Grade 1 peripheral neuropathy
- Active or chronic corneal disorder, including but not limited to the following:
Show all 22Show fewer
- Sjogren's syndrome
- Fuchs corneal dystrophy (requiring treatment)
- History of corneal transplantation
- Active herpetic keratitis
- Active ocular conditions requiring on-going treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision.
- Serious concurrent illness or clinically-relevant active infection
- Cytomegalovirus infection
- Any concurrent infectious disease, requiring IV antibiotics within 2 weeks of first dose of mirvetuximab soravtansine
- Significant cardiac disease including
- History of neurological conditions that would confound assessment of treatment-emergent neuropathy other than ≤ Grade 1 peripheral neuropathy including multiple sclerosis or other demyelinating disease and/or eaton-lambert syndrome (para-neoplastic syndrome)" Diabetes is allowed.
- History of hemorrhagic or ischemic stroke within 6 months prior to first dose of mirvetuximab soravtansine
- History of cirrhotic liver disease
- Previous clinical diagnosis of non-infectious pneumonitis or non-infectious interstitial lung disease
- Prior hypersensitivity to monoclonal antibodies
- History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to first dose of mirvetuximab soravtansine
- Required used of folate-containing supplements (e.g. for folate deficiency)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha (FRα)-Expressing, Triple Negative Breast Cancer (TNBC) With Residual Disease Post Standard Neoadjuvant Chemotherapy
The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects the amount and activity of folate receptor alpha proteins in tumor cells of patients who have completed standard neoadjuvant treatment and are scheduled to have their tumors surgically removed.
Read the detailed description
The folate receptor alpha protein is important in tumor growth and can be over-expressed in some tumor cells. The word "over-expressed" in this situation means that there are too many copies of the protein on the surface of the cell when compared to a healthy, normal cell, and this helps the tumor continue to grow in size. Mirvetuximab soravtansine acts by targeting the folate receptor in tumor cells. In animal models, mirvetuximab soravtansine is highly effective in decreasing tumor size. This suggests that mirvetuximab soravtansine may help shrink or stop growth of folate receptor alpha positive breast cancer in this study.
In this study the investigator will be looking at how folate receptor alpha expression changes following 2 doses of neoadjuvant mirvetuximab soravtansine. The investigator will also look to evaluate the safety of this regimen, measure any change in tumor size, associate folate receptor alpha expression with a change in tumor size, and describe any changes in Ki-67 and percent of apoptotic cells in this population.
- Conditions
- Breast Cancer Triple Negative
- Being tested
- Mirvetuximab Soravtansine (IMGN853)
- Keywords
- Neoadjuvant, Breast Cancer, Folate Receptor Alpha, FRa, TNBC, Triple Negative Breast Cancer, Preoperative, Presurgery, Mirvetuximab Soravtansine, IMGN853
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirvetuximab Soravtansine (IMGN853)Drug
Mirvetuximab Soravtansine is a targeted drug for tumors that express high levels of folate receptor alpha.
| Study group | Role | What they receive |
|---|---|---|
| Mirvetuximab Soravtansine | Experimental | Participants will receive 2 doses of Mirvetuximab Soravtansine after neoadjuvant chemotherapy and before surgical resection of tumor. Receives: Drug: Mirvetuximab Soravtansine (IMGN853) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast tumor FRα expression before and after treatment with mirvetuximab soravtansine
Assessed by immunohistochemistry (IHC) (1) after completion of neoadjuvant chemotherapy, prior to treatment with mirvetuximab soravtansine; (2) at definitive surgery, after treatment with mirvetuximab soravtansine and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors).
Measured: Baseline up to 9 weeks
Secondary outcomes (7)
Change in breast tumor FRα expression before and after neoadjuvant chemotherapy
Assessed by immunohistochemistry (IHC) (1) at initial cancer diagnosis, prior to initiation of neoadjuvant chemotherapy; (2) after completion of neoadjuvant chemotherapy and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors).
Measured: Baseline up to 9 weeks
Total number of grade 3 and 4 toxicities
Graded via NCI CTCAE v4.03
Measured: Baseline up to 9 weeks
Number of treatment-emergent adverse events (TEAEs) precluding second dose
Assessed by the number of subjects that cannot receive the second dose of mirvetuximab soravtansine
Measured: Baseline up to 9 weeks
Number of treatment-emergent adverse events (TEAEs) delaying surgery
Assessed by the number of subjects that have surgery delayed past 9 weeks due to TEAE
Measured: Baseline up to 9 weeks
Total number of partial or complete responses
Evaluated by the number of subjects that have either a partial or complete radiologic response by 2D ultrasound. (Partial response = reduction of the largest unidimensional tumor measurement of >30%; Complete response = no evidence of tumor remaining)
Measured: Baseline up to 9 weeks
Change in tumor cell proliferation, as measured by Ki67 expression
Changes in Ki67 expression will be measured before and after 2 doses of mirvetuximab soravtansine.
Measured: Baseline up to 9 weeks
Change in tumor cell death markers
Changes in apoptotic markers will be measured before and after 2 doses of mirvetuximab soravtansine.
Measured: Baseline up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start17 Apr 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Triple NegativeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Kimberly Blackwell, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045393
- Sponsor's protocol ID
- Pro00074621
- Acronym
- IMGN853
- Status last verified
- Mar 2018
- First submitted
- 3 Feb 2017
- Last updated
- 5 Jul 2018
- 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 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha (FRα)-Expressing, Triple Negative Breast Cancer (TNBC) With Residual Disease Post Standard Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03045393
- Acronym / sponsor ID
- IMGN853 / Pro00074621
- Conditions
- Breast Cancer Triple Negative
- Keywords
- Neoadjuvant, Breast Cancer, Folate Receptor Alpha, FRa, TNBC, Triple Negative Breast Cancer, Preoperative, Presurgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 7 Feb 2017 (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.
The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects the amount and activity of folate receptor alpha proteins in tumor cells of patients who have completed standard neoadjuvant treatment and are scheduled to have their tumors surgically removed.
Detailed description
The folate receptor alpha protein is important in tumor growth and can be over-expressed in some tumor cells. The word "over-expressed" in this situation means that there are too many copies of the protein on the surface of the cell when compared to a healthy, normal cell, and this helps the tumor continue to grow in size. Mirvetuximab soravtansine acts by targeting the folate receptor in tumor cells. In animal models, mirvetuximab soravtansine is highly effective in decreasing tumor size. This suggests that mirvetuximab soravtansine may help shrink or stop growth of folate receptor alpha positive breast cancer in this study.
In this study the investigator will be looking at how folate receptor alpha expression changes following 2 doses of neoadjuvant mirvetuximab soravtansine. The investigator will also look to evaluate the safety of this regimen, measure any change in tumor size, associate folate receptor alpha expression with a change in tumor size, and describe any changes in Ki-67 and percent of apoptotic cells in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirvetuximab Soravtansine | Experimental | Drug: Mirvetuximab Soravtansine (IMGN853)Participants will receive 2 doses of Mirvetuximab Soravtansine after neoadjuvant chemotherapy and before surgical resection of tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent and HIPAA authorization for release of personal health information.
- Must have operable tumor ≥ 1cm determined by and obtained less than 9 weeks after completion of standard NAC
- Must be able to meet study schedule: 2 doses of mirvetuximab soravtansine administered 3 weeks apart and surgery within 9 weeks of last dose of NAC.
- Willing to undergo biopsy for research purposes only (before and after), and to allow surgical tissue sample from surgery to be used for research purposes
- May have symptoms however must be ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work)
Key exclusion criteria (22 listed)
- Pregnant or breastfeeding, or plan to be pregnant within projected duration of the trial. (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has a known additional malignancy that is active and/or progressive requiring treatment within 3 years of first dose.
- Prior treatment with mirvetuximab soravtansine
- Treatment with any investigational drug within 6 weeks of first clinical dose
- Subjects with > Grade 1 peripheral neuropathy
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 |
|---|---|---|
| Mirvetuximab Soravtansine (IMGN853)Mirvetuximab Soravtansine is a targeted drug for tumors that express high levels of folate receptor alpha. | Drug | Mirvetuximab Soravtansine |
Primary outcome
Change in breast tumor FRα expression before and after treatment with mirvetuximab soravtansine
Time frame: Baseline up to 9 weeks
Assessed by immunohistochemistry (IHC) (1) after completion of neoadjuvant chemotherapy, prior to treatment with mirvetuximab soravtansine; (2) at definitive surgery, after treatment with mirvetuximab soravtansine and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors).
7 secondary outcomes
Change in breast tumor FRα expression before and after neoadjuvant chemotherapy
Time frame: Baseline up to 9 weeks
Total number of grade 3 and 4 toxicities
Time frame: Baseline up to 9 weeks
Number of treatment-emergent adverse events (TEAEs) precluding second dose
Time frame: Baseline up to 9 weeks
Number of treatment-emergent adverse events (TEAEs) delaying surgery
Time frame: Baseline up to 9 weeks
Total number of partial or complete responses
Time frame: Baseline up to 9 weeks
Change in tumor cell proliferation, as measured by Ki67 expression
Time frame: Baseline up to 9 weeks
Change in tumor cell death markers
Time frame: Baseline up to 9 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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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.
Kimberly Blackwell, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mirvetuximab Soravtansine (IMGN853) in people with Breast Cancer Triple Negative, run by Duke University at 1 site 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 8 inclusion and 22 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: withdrawn, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in breast tumor FRα expression before and after treatment with mirvetuximab soravtansine (time frame: Baseline up to 9 weeks). 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 5 Jul 2018.