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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

Status: Recruiting
Phase: Phase 1
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01609556 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-312

 

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

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Michael Birrer, MD, PhD, Massachusetts General Hospital

Site-responsible Investigators:
Ursula Matulonis, MD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

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.
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