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 (IMGN-0401)
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ClinicalTrials.gov Identifier: NCT01609556 |
Recruitment Status : Unknown
Verified June 2018 by ImmunoGen, Inc..
Recruitment status was: Active, not recruiting
First Posted : June 1, 2012
Last Update Posted : June 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
FOLR-1 Positive Solid Tumors | Drug: IMGN853 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 205 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | April 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: IMGN853 |
Drug: IMGN853
Dose escalation study. Dosing on day 1 of every 21 day cycle. |
- Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of IMGN853 [ Time Frame: During study ]
- Evaluate the safety and tolerability of IMGN853 [ Time Frame: During the study ]
- Characterize the pharmacokinetics of IMGN853 [ Time Frame: During the study ]
- Assess IMGN853 pharmacodynamic activity [ Time Frame: During the study ]
- Characterize the immunogenicity of IMGN853 [ Time Frame: During the study ]
- Describe any preliminary evidence of IMGN853 antitumor activity [ Time Frame: During the study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609556
United States, Kansas | |
University of Kansas Medical Center Research Institute | |
Fairway, Kansas, United States, 66205 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02062 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Oklahoma | |
University of Oklahoma Stephenson Cancer Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
CTRC at the University of Texas Health Science Center | |
San Antonio, Texas, United States, 78229 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
McGill University Health Centre | |
Montreal, Quebec, Canada, H4A3J1 |
Responsible Party: | ImmunoGen, Inc. |
ClinicalTrials.gov Identifier: | NCT01609556 |
Other Study ID Numbers: |
IMGN853-0401 |
First Posted: | June 1, 2012 Key Record Dates |
Last Update Posted: | June 7, 2018 |
Last Verified: | June 2018 |
FOLR solid tumors |