Actively Recruiting
Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer
Led by Alessandro Santin · Updated on 2025-07-18
50
Participants Needed
1
Research Sites
428 weeks
Total Duration
On this page
Sponsors
A
Alessandro Santin
Lead Sponsor
I
ImmunoGen, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the activity and safety profile of mirvetuximab soravtansine (IMGN853) in patients with type II endometrial cancers that overexpress folate receptor alpha (FRα).
CONDITIONS
Official Title
Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiologically confirmed persistent or recurrent endometrial cancer
- Pathologically confirmed uterine serous carcinoma (pure or mixed), Grade 2 or 3 endometrial adenocarcinoma, carcinosarcoma with high-grade serous or Grade 2/3 endometrioid components, or clear cell carcinoma (pure or mixed)
- Measurable disease
- Folate receptor alpha-positive tumor expression
- At least one target lesion measurable by RECIST v1.1
- Received no more than 3 prior lines of therapy for recurrent disease (hormonal agents not counted)
- No prior treatment with folate receptor-targeting investigational agents
- ECOG performance status of 0 or 1
- Adequate time since prior therapy: systemic therapy (five half-lives or 4 weeks, whichever is shorter), radiotherapy (wide-field at least 4 weeks or focal at least 2 weeks)
- Resolution of toxic effects from prior chemotherapy
- Adequate hematologic, liver, and kidney function
- Women of childbearing potential must use effective contraception during treatment and for 12 weeks after last dose
- Negative pregnancy test within 4 days before first dose
- Either optimally or suboptimally debulked at initial surgery
- Age 18 years or older
- Signed informed consent and agree to study schedule and requirements
You will not qualify if you...
- Active or chronic corneal disorder
- Serious concurrent illness or clinically relevant active infection
- Significant cardiac disease including recent myocardial infarction (within 6 months), unstable angina, uncontrolled heart failure or hypertension, arrhythmias, vascular disease, severe aortic stenosis, or prior cardiac toxicity from chemotherapy
- History of neurological conditions
- Hemorrhagic or ischemic stroke within last 6 months
- Cirrhotic liver disease
- Previous diagnosis of non-infectious pneumonitis
- Prior hypersensitivity to monoclonal antibodies
- Pregnant or breastfeeding women
- Carcinomatous meningitis, untreated CNS disease or symptomatic CNS metastases
- History or evidence of thrombotic or hemorrhagic disorders within 6 months
- Use of folate-containing supplements
- Known additional malignancy progressing or requiring treatment within 3 years before first study dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
A
Alessandro D. Santin, M.D.
CONTACT
L
Lisa Baker, R.N.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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