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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

At time of initial surgery, patient may have either been optimally or suboptimally debulked

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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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My initial surgery removed most or all of my tumor.

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I am 18 years old or older.

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I have recovered from the side effects of my last chemotherapy.

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I've had up to 3 treatments for my recurring cancer, not counting hormone therapy, and none targeted the folate receptor.

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My blood, liver, and kidney functions are all within normal ranges.

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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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It's been weeks since my last cancer treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

Durable disease control rate (DDCR)

Duration of overall survival (OS)

Duration of progression free survival (PFS)

+1 more

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)

0 / 10Eligibility criteria met

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

3,855 Total Patients Enrolled

3 Trials studying Endometrial Cancer

262 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment exclude patients who are octogenarians?

"The patients that this study hope to include are between 18 and 100 years old."

Answered by AI

How many people have signed up to participate in this clinical trial thus far?

"That is correct, the clinical trial detailed on clinicaltrials.gov is still ongoing and looking for patients to enroll. The 50 openings are at a single location. This information was most recently updated on 8/10/2022, with the original posting date being 7/15/2020."

Answered by AI

Could I be a potential subject for this research?

"This study is recruiting 50 patients, between the ages of 18 and 100 who have endometrial neoplasms. It is required that participants also meet the following criteria: 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, or Carcinosarcoma with high grade serous or Grade 2/3 endometrioid components, Have measurable disease, Have at least one "target lesion" to be used to assess response as defined by RECIST v1"

Answered by AI

What is the federal government's official stance on IMGN853?

"IMGN853's safety is based on preliminary data and received a score of 2."

Answered by AI

What other research has been conducted using IMGN853?

"At the moment, there are 9 different ongoing clinical trials for IMGN853. 2 of those studies have reached Phase 3 and are still recruiting patients. Although most of the research is based in Columbus, Ohio, 402 medical facilities across the United States are running these types of tests."

Answered by AI

Are patients being actively signed up for this experiment?

"The clinical trial is currently underway and actively recruiting patients, as indicated by the listing on clinicaltrials.gov. This particular study was posted on 7/15/2020 and last updated on 8/10/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Alessandro Santin 2020. "Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03832361.

All > Endometrial Cancer