Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-24 @ 12:04 PM
NCT ID:
NCT03832361
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03832361
Study Brief:
Protocol Section:
NCT03832361