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 (IMGN-0401)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by ImmunoGen, Inc.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT01609556
First received: May 30, 2012
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
FOLR-1 Positive Solid Tumors
Drug: IMGN853
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of IMGN853 [ Time Frame: During study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability of IMGN853 [ Time Frame: During the study ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics of IMGN853 [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Assess IMGN853 pharmacodynamic activity [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Characterize the immunogenicity of IMGN853 [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Describe any preliminary evidence of IMGN853 antitumor activity [ Time Frame: During the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 185
Study Start Date: May 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: IMGN853
    Dose escalation study. Dosing on day 1 of every 21 day cycle.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, including Sjogren's syndrome.
  • Serious concurrent illness:
  • Any other concomitant anti-cancer treatment.
  • Receiving anticoagulation with therapeutic doses of warfarin.
  • Women of childbearing potential who are pregnant or breast feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609556

Locations
United States, Kansas
University of Kansas Medical Center Research Institute Recruiting
Fairway, Kansas, United States, 66205
Contact: Kerry Hepler    913-945-7552    khepler@kumc.edu   
Principal Investigator: Raymond Perez, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02062
Contact: Tina Atkinson    617-643-5150    Tina_Atkinson@dfci.harvard.edu   
Principal Investigator: Michael J Birrer, M.D., Ph.D.         
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Courtney Whalen    315-576-9698    whalenc@karmanos.org   
Principal Investigator: Shelly Seward, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Katie Grant    614-366-9227    katie.grant@osumc.edu   
Principal Investigator: David O'Malley, MD         
United States, Oklahoma
University of Oklahoma Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Julie Curiel    405-271-8001 ext 48158    julie-curiel@ouhsc.edu   
Principal Investigator: Kathleen Moore, M.D.         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Patricia Murphy-Kelly    215-728-2195    Patricia.Murphy@fccc.edu   
Principal Investigator: Hossein Borghaei, MS, DO         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kimberly McKenzie    615-524-4255    Kimberly.McKenzie@scresearch.net   
Contact: Lorie Patterson    615-329-7289    lorie.patterson@scresearch.net   
Principal Investigator: Todd M Bauer, MD         
United States, Texas
CTRC at the University of Texas Health Science Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Leslie Wood, RN, BSN, OCN    210-450-5962    woodl3@uthscsa.edu   
Principal Investigator: Steven Weitman, M.D.         
Sponsors and Collaborators
ImmunoGen, Inc.
  More Information

No publications provided

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT01609556     History of Changes
Other Study ID Numbers: IMGN853-0401
Study First Received: May 30, 2012
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
FOLR solid tumors

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on October 01, 2014