Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC

NCT03045393 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: Pro00074621
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Triple Negative

Keywords

Neoadjuvant; Breast Cancer; Folate Receptor Alpha; FRa; TNBC; Triple Negative Breast Cancer; Preoperative; Presurgery; Mirvetuximab Soravtansine; IMGN853

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline up to 9 weeks

Secondary Outcomes (7)

• Change in breast tumor FRα expression before and after neoadjuvant chemotherapy

  Baseline up to 9 weeks

• Total number of grade 3 and 4 toxicities

  Baseline up to 9 weeks

• Number of treatment-emergent adverse events (TEAEs) precluding second dose

  Baseline up to 9 weeks

• Number of treatment-emergent adverse events (TEAEs) delaying surgery

  Baseline up to 9 weeks

• Total number of partial or complete responses

  Baseline up to 9 weeks

Study Arms (1)

Mirvetuximab Soravtansine

EXPERIMENTAL

Participants will receive 2 doses of Mirvetuximab Soravtansine after neoadjuvant chemotherapy and before surgical resection of tumor.

Drug: Mirvetuximab Soravtansine (IMGN853)

Interventions

Mirvetuximab Soravtansine (IMGN853) DRUG

Mirvetuximab Soravtansine is a targeted drug for tumors that express high levels of folate receptor alpha.

Mirvetuximab Soravtansine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed screening consent form with HIPAA authorization for release of personal health information.
• Research personnel will review medical records of subjects consenting to screening to ensure no obvious factors would exclude them from the treatment portion of the study (e.g., history of cirrhosis of the liver) and to confirm diagnosis and staging
• Histological confirmation of triple negative breast cancer (TNBC) biopsy report
• Stage 1-3 tumors \> 1cm in maximal diameter.
• Standard neoadjuvant chemotherapy NAC and definitive surgery planned (NOTE: NAC chemotherapy will be per standard of care, and not dictated by this clinical trial)
• Must be able to supple sufficient tissue (block or slides) from diagnostic biopsy to undergo testing.
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Duke University: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

mirvetuximab soravtansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kimberly Blackwell, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: April 17, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-03

Locations

US (1)