First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
Condition: Tumors
Intervention: Mirvetuximab soravtansine
Intervention description: Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.
Intervention MeSH terms: Maytansine; Mirvetuximab soravtansine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FOLR-1 solid tumors

Summary:

      The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with
      ovarian cancer and other FOLR-1 positive tumors.
    

Eligibility criteria:

        Inclusion Criteria

          -  Participants with advanced solid tumor that is refractory to standard treatment, for
             which no standard treatment is available, or the participant refuses standard therapy.

          -  Participants must be willing to provide an archival tumor tissue block or slides for
             biomarker analysis.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

          -  Time from prior therapy:

               1. Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is
                  shorter (6 weeks for prior nitrosoureas or mitomycin C).

               2. Radiotherapy: wide-field radiotherapy (for example, greater than [>] 30 percent
                  [%] of marrow-bearing bones) completed at least four weeks, or focal radiation
                  completed at least two weeks, prior to starting study drug.

          -  Participants must have recovered or stabilized from all therapy-related toxicities.

          -  Major surgery (not including placement of vascular access device or tumor biopsies)
             must be completed four weeks prior to Day 1. Participants must have recovered or
             stabilized from the side effects prior to study treatment.

          -  Participants must have adequate hematologic, liver and kidney function.

          -  Participants with central nervous system (CNS) disease involvement are eligible if
             they have had brain metastases resected or have received radiation therapy ending at
             least 4 weeks prior to study day 1 and they meet all of the following criteria:
             Residual neurological symptoms less than or equal to (<=) Grade 1; No dexamethasone
             requirement; and Follow-up magnetic resonance imaging (MRI) shows no progression of
             treated lesions and no new lesions appearing.

          -  Participants must be willing and able to sign the informed consent form, and to adhere
             to the study visit schedule and other protocol requirements.

          -  Women of childbearing potential and men must agree to use effective contraceptive
             methods while on study and for at least twelve weeks after the last dose of study
             drug.

          -  Women of childbearing potential must have a negative pregnancy test prior to the first
             dose of study treatment.

        Exclusion Criteria

          -  Grade >1 neuropathy.

          -  Any active or chronic corneal disorder, including, but not limited to the following:
             Sjogren's syndrome, Fuch's corneal dystrophy (requiring treatment), history of corneal
             transplantation, active herpetic keratitis, and also active ocular conditions
             requiring ongoing treatment/monitoring such as wet age-related macular degeneration
             requiring intravitreal injections, active diabetic retinopathy with macular edema,
             presence of papilledema, acquired monocular vision.

          -  Serious concurrent illness, including, but not limited to the following:

               1. Clinically relevant active infection including known active hepatitis B or C,
                  Human Immunodeficiency Virus (HIV) infection, varicella-zoster virus (shingles)
                  or cytomegalovirus infection or any other known concurrent infectious disease,
                  requiring IV antibiotics within 2 weeks of study enrollment.

               2. Significant cardiac disease such as recent myocardial infarction (<=6 months
                  prior to Day 1), unstable angina pectoris, uncontrolled congestive heart failure
                  (New York Heart Association >class II), uncontrolled hypertension (greater than
                  or equal to [>=] Common Terminology Criteria for Adverse Events Version 4.03
                  [CTCAE v4.03] Grade 3), uncontrolled cardiac arrhythmias, severe aortic stenosis,
                  or >=Grade 3 cardiac toxicity following prior chemotherapy.

               3. History of multiple sclerosis or other demyelinating disease, Eaton-Lambert
                  syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke
                  within the last six months, or alcoholic liver disease.

               4. Previous clinical diagnosis of treatment-related pneumonitis.

          -  Any other concomitant anti-cancer treatment such as immunotherapy, biotherapy,
             radiotherapy, chemotherapy, investigative therapy, or high-dose steroids; however, low
             dose steroids and Luteinizing Hormone Releasing Hormone (LHRH) at doses that have been
             stable for >=14 days are permitted for participants with prostate cancer.

          -  Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids.

          -  Prior history of solid tumor malignancy within the last 3 years except for adequately
             treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ
             breast cancer, in situ prostate cancer (participants must have shown no evidence of
             active disease for 2 years prior to enrollment).

          -  Concomitant administration of folate-containing vitamins.

          -  Participants who have received prior allogeneic or autologous bone marrow transplants.

          -  Women of childbearing potential who are pregnant or breast feeding.