Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 100 Years
• SexFemale
• Healthy volunteersNo

You may be able to join if

• Radiologically confirmed (ie, CT scan and/or MRI) persistent or recurrent endometrial cancer
• Patients must have one of the following pathologically documented, definitively diagnosed tumor types: Uterine serous carcinoma (Pure or Mixed), Grade 2 or Grade 3 endometrial adenocarcinoma, Carcinosarcoma with high grade serous or Grade 2/3 endometrioid components, or clear cell carcinoma (Pure or Mixed).
• Have measurable disease
• FRα-positive tumor expression as defined in the protocol
• Have at least one "target lesion" to be used to assess response as defined by RECIST v1.1
• Patients must have received prior treatment with ≤ 3 prior lines of therapy for recurrent disease; hormonal agents are not considered a line of therapy; prior treatment with folate receptor-targeting investigational agents is not allowed
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Time from prior therapy: Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter; Radiotherapy: wide-field radiotherapy completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
• Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy
• Patients must have adequate hematologic, liver and kidney function as defined in the protocol
• Women of child bearing potential (WCBP), must agree to use effective contraceptive methods during study treatment and for at least twelve weeks after the last dose of IMGN853
• WCBP must have a negative pregnancy test within 4 days prior to the first dose of study treatment
• At time of initial surgery, patient may have either been optimally or suboptimally debulked
• Have signed the informed consent form, and willing to adhere to the study visit schedule and other protocol requirements
• ≥ 18 years of age

You cannot join if

• Active or chronic corneal disorder
• Serious concurrent illness or clinically-relevant active infection as defined in the protocol
• Clinically-significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled cardiac arrhythmias, clinically-significant vascular disease, severe aortic stenosis, clinically significant peripheral vascular disease, or cardiac toxicity following prior chemotherapy
• History of neurological conditions
• History of hemorrhagic or ischemic stroke within the last 6 months
• History of cirrhotic liver disease
• Previous clinical diagnosis of non-infectious pneumonitis
• Prior hypersensitivity to monoclonal antibodies
• Women who are pregnant or breast feeding
• Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis
• History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
• Required used of folate-containing supplements (e.g. folate deficiency)
• Has a known additional malignancy that is progressing or required active treatment within 3 years of first dose of study treatment

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

mirvetuximab soravtansine. An immunoconjugate consisting of the humanized monoclonal antibody M9346A against folate receptor 1 (FOLR1) conjugated, via the disulfide-containing cleavable linker sulfo-SPDB, to the cytotoxic maytansinoid DM4, with potential antineoplastic activity. The anti-FOLR1 monoclonal antibody moiety of mirvetuximab soravtansine targets and binds to the cell surface antigen FOLR1. After antibody-antigen interaction and internalization, the immunoconjugate releases DM4, which binds to tubulin and disrupts microtubule assembly/disassembly dynamics, thereby inhibiting cell division and cell growth of FOLR1-expressing tumor cells. FOLR1, a member of the folate receptor family is overexpressed on a variety of epithelial-derived cancer cells. The sulfo-SPDB linker prevents cleavage in the bloodstream and may improve this agent's efficacy in multidrug resistant tumor cells. NCI Drug Dictionary

Treatments listed in the registry

• IMGN853 (Drug): IMGN853 6 mg/kg intravenously every 3 weeks until disease progression

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• CT scans: Part of the study plan

Main goals

• Objective response rate (ORR) (5 Years)

Other goals

• Duration of overall survival (OS)
• Duration of progression free survival (PFS)
• Durable disease control rate (DDCR)
• Safety profile of mirvetuximab soravtansine (IMGN853) in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)

Planned enrollment: 50 (estimated).

• Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT03832361
• NCI Drug Dictionary: C102566

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 25, 2026. Public record; not medical advice.