First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors



Status:Active, not recruiting
Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/9/2018
Start Date:May 2012
End Date:April 2019

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A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors

The purpose of this study is to test IMGN853 in patients with FOLR-1 positive tumors.


Criteria for Selection of Patient Population Inclusion Criteria

- Patients with advanced solid tumor that is refractory to standard treatment, for which
no standard treatment is available, or the patient refuses standard therapy.

- ≥ 18 years old at the time of informed consent.

- ECOG Performance Status 0 or 1.

- Patients must have adequate hematologic and organ function.

- Patients must be willing and able to sign the informed consent form, and to follow the
study visit schedule and other protocol requirements.

- Women of childbearing potential and men must agree to use effective contraceptive
methods while on study and for at least twelve weeks after the last dose of study
drug.

- Women of childbearing potential must have a negative pregnancy test prior to the first
dose of study treatment.

Exclusion Criteria

- Grade >1 neuropathy

- Any active or chronic corneal disorder and Sjogren's syndrome.

- Serious concurrent illness:

- Any other concomitant anti-cancer treatment.

- Women of childbearing potential who are pregnant or breast feeding.
We found this trial at
11
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Michael J Birrer, M.D., Ph.D.
Phone: 617-643-5150
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Boston, MA
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4100 John R
Detroit, Michigan 48201
800-527-6266
Principal Investigator: Shelly Seward, MD
Phone: 315-576-9698
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Ursula A Matulonis, MD
Phone: 617-632-3346
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: David O'Malley, MD
Phone: 614-366-9227
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Fairway, Kansas 66205
Principal Investigator: Raymond Perez, MD
Phone: 913-945-7552
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Fairway, KS
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Todd M Bauer, MD
Phone: 615-524-4399
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Jason Konner, MD
Phone: 646-497-9055
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Oklahoma City, Oklahoma 73104
Principal Investigator: Kathleen Moore, M.D.
Phone: 405-271-8001
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19111
Principal Investigator: Hossein Borghaei, MS, DO
Phone: 215-728-2195
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San Antonio, Texas 78229
Principal Investigator: Steven Weitman, M.D.
Phone: 210-450-5962
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Toronto, Ontario
Principal Investigator: Amit Oza, MD
Phone: 416-946-2818
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Toronto,
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