New drug aimed at folate receptor shows promise for tough endometrial cancer
NCT ID NCT03832361
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a drug called mirvetuximab soravtansine in 50 women with a specific type of endometrial cancer that has come back or won't go away. The drug targets a protein called folate receptor alpha, which is often found on these cancer cells. Researchers want to see if the drug can shrink tumors and how safe it is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mirvetuximab soravtansine (IMGN853)
- What this could lead to
- If successful, this could provide a new treatment option for women with a hard-to-treat form of endometrial cancer that has come back.
- What could go wrong
- This is a small, early-phase trial with only 50 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Smilow Cancer Hospital at Yale New Haven
RECRUITINGNew Haven, Connecticut, 06510, United States
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