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Monoclonal Antibodies

IMGN853 for Endometrial Cancer

Phase 2
Recruiting
Led By Alessandro D. Santin, M.D.
Research Sponsored by Alessandro Santin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
FRα-positive tumor expression as defined in the protocol
≥ 18 years of age
Must not have
Active or chronic corneal disorder
Has a known additional malignancy that is progressing or required active treatment within 3 years of first dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new drug, IMGN853, on patients with a specific type of endometrial cancer. The goal is to see if the drug is active and safe.

Who is the study for?
This trial is for women with certain types of advanced endometrial cancer that have a protein called FRα. They must have tried ≤3 treatments, not be pregnant, agree to contraception, and can't have had certain heart issues, brain conditions or other serious health problems.
What is being tested?
The study tests the effectiveness and safety of a drug named Mirvetuximab Soravtansine (IMGN853) in patients with type II endometrial cancers overexpressing folate receptor alpha. It's for those who've had previous treatments but still show signs of cancer.
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, fatigue, nausea, blood count changes and potential allergic responses due to its nature as a monoclonal antibody.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is FRα-positive.
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I am 18 years old or older.
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My endometrial cancer has come back or didn't go away, confirmed by a scan.
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My cancer is one of the specified types of uterine or endometrial cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an ongoing eye condition affecting my cornea.
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I have another cancer that is getting worse or needed treatment in the last 3 years.
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I do not have serious heart or blood vessel problems.
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I have a history of neurological conditions.
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I am not pregnant or breastfeeding.
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I am taking supplements that contain folate due to a deficiency.
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I have been diagnosed with non-infectious lung inflammation before.
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I do not have untreated brain-related cancer issues.
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I have a history of liver cirrhosis.
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I have not had a stroke in the past 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Durable disease control rate (DDCR)
Duration of overall survival (OS)
Duration of progression free survival (PFS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IMGN853Experimental Treatment1 Intervention
IMGN853 administered 6 mg/kg adjusted ideal body weight (AIBW) once every three weeks (Q3W)

Find a Location

Who is running the clinical trial?

Alessandro SantinLead Sponsor
3 Previous Clinical Trials
90 Total Patients Enrolled
ImmunoGen, Inc.Industry Sponsor
32 Previous Clinical Trials
3,971 Total Patients Enrolled
3 Trials studying Endometrial Cancer
441 Patients Enrolled for Endometrial Cancer
Alessandro D. Santin, M.D.Principal InvestigatorYale University
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Mirvetuximab Soravtansine (IMGN853) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03832361 — Phase 2
Endometrial Cancer Research Study Groups: IMGN853
Endometrial Cancer Clinical Trial 2023: Mirvetuximab Soravtansine (IMGN853) Highlights & Side Effects. Trial Name: NCT03832361 — Phase 2
Mirvetuximab Soravtansine (IMGN853) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03832361 — Phase 2
~7 spots leftby Oct 2025
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