First in Human Study of IMGN151 in Recurrent Gynaecological Cancers
NCT ID: NCT05527184
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
423 participants
INTERVENTIONAL
2023-01-11
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IMGN151
IMGN151 is administered via intravenous (IV) infusion on Day 1 of Cycle 1 every 3-week cycle (Q3W).
IMGN151
IMGN151 is an antibody-drug conjugate (ADC).
Interventions
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IMGN151
IMGN151 is an antibody-drug conjugate (ADC).
Eligibility Criteria
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Inclusion Criteria
2. Dose-Escalation Phase: Recurrent endometrial cancer or high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC) and who have exhausted appropriate standard-of-care therapy.
3. Dose Optimization: Platinum-resistant, high-grade serous EOC (PROC) with no previous folate receptor alpha (FRα)-directed therapy. Participants with PROC will have had no more than 5 prior lines of therapy, with no more than 2 prior therapies since development of platinum resistance.
4. Expansion Phase:
1. For Cohort A, recurrent endometrial cancer (high-grade endometrioid or serous histology only) with 1-3 prior lines of therapy.
2. For Cohort B, PROC with no previous FRα-directed therapy and no more than 5 prior lines of therapy, with no more than 2 prior therapies since development of platinum resistance.
3. For Cohort C, PROC with previous FRα-directed therapy with at least one intervening anticancer therapy between prior FRα-directed therapy and IMGN151.
4. For Cohort D, EOC of one of the following histologies: carcinosarcoma, endometrioid, and low-grade serous carcinoma and have exhausted appropriate standard-of-care therapy.
5. For Cohort E, cervical cancer including the following histologies: squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma with 1-4 prior lines of therapy.
6. For participants with cervical cancer with Combined Positive Score (CPS) \> 1 or with endometrial cancer, prior checkpoint inhibitor therapy, alone or in combination, is required if available locally and medically appropriate.
5. Evaluable lesions
1. Dose-Escalation Phase: Participants may have radiologically evaluable or nonevaluable disease.
2. Dose Optimization and Expansion Phase: Participants must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
6. Willing to provide an archival tumor tissue block or slides or to undergo a procedure to obtain a new biopsy using a low-risk, medically routine procedure.
7. Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia or hemoglobin within 10 days before Cycle 1 Day 1).
8. Participants must have completed any major surgery at least 4 weeks prior to first dose of IMGN151 and have recovered or stabilized from the side effects of prior surgery prior to first dose of IMGN151.
9. Participants must have adequate organ and bone marrow function.
Exclusion Criteria
1. With the exception of participants enrolled in Cohort D, participants with ovarian cancer with histologies including endometrioid, sarcomatous histology, mixed tumors containing any of the above histologies, as well as low-grade serous carcinoma.
2. For Cohort A, participants with endometrial cancer with histologies other than high-grade serous or high-grade endometrioid.
3. For Cohort E, participants with cervical cancer with histologies other than adenocarcinoma, squamous cell carcinoma, and adenosquamous carcinoma.
2. For Cohort B and Dose Optimization: participants with primary platinum refractory ovarian cancer, defined as disease progression on or within 3 months completion of first platinum-based treatment.
3. Radiation therapy of \> 20% of the potential bone marrow
4. Participants with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
5. Participants with the following ocular history and/or concurrent disorders:
1. Active or chronic corneal epithelial disorders other than non-confluent superficial keratopathy/keratitis, including confluent superficial punctate keratopathy/keratitis (SPK) not expected to resolve to non-confluence or better within the screening window with standard-of-care intervention
2. History of corneal transplantation
3. Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery
4. Active or chronic clinically significant (≥ Grade 3) corneal disorders (for example, Fuch's dystrophy or neurotrophic keratitis)
5. Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, an ocular condition with high risk of retinal detachment
6. Monocular vision with visual acuity in the worse-seeing eye (worse than 20/200 or visual fields less than 20 degrees)
6. Serious concurrent illness or clinically relevant active infection.
7. A history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
8. Participants with clinically significant cardiac disease.
9. A history of hemorrhagic or ischemic stroke within 6 months before enrollment
10. A history of cirrhotic liver disease (Child-Pugh Class B or C)
11. Participants with evidence of pneumonitis on baseline imaging or Participants with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
12. Participants with prior hypersensitivity to monoclonal antibodies (mAb)
13. Females who are pregnant or breastfeeding
14. For Dose Optimization and Expansion Phase: Participants who received a prior FRα-targeting agent, with the exception of participants enrolled in the prior FRα-targeting agent, ovarian cancer cohort (Cohort C).
15. Untreated or symptomatic central nervous system metastases
16. A history of other malignancy within 3 years before enrollment
18 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama at Birmingham /ID# 269045
Birmingham, Alabama, United States
City of Hope National Medical Center /ID# 269036
Duarte, California, United States
Moores Cancer Center /ID# 269040
La Jolla, California, United States
University of California Los Angeles Medical Center /ID# 269037
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian /ID# 269047
Newport Beach, California, United States
UCHSC Anschultz Cancer Pavilion /ID# 269056
Aurora, Colorado, United States
AdventHealth Celebration /ID# 269030
Kissimmee, Florida, United States
Mount Sinai Medical Center /ID# 269050
Miami, Florida, United States
Miami Cancer Institute at Baptist Health /ID# 269041
Miami, Florida, United States
Florida Cancer Specialists- Sarasota Cattlemen /ID# 269055
Sarasota, Florida, United States
University of Chicago Medical Center /ID# 269028
Chicago, Illinois, United States
Massachusetts General Hospital /ID# 278119
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 269039
Boston, Massachusetts, United States
Karmanos Cancer Institute - Detroit /ID# 269052
Detroit, Michigan, United States
University of Mississippi Medical Cancer Center /ID# 269046
Jackson, Mississippi, United States
Washington University School of Medicine - St. Louis /ID# 269048
St Louis, Missouri, United States
Holy Name Medical Center /ID# 269051
Teaneck, New Jersey, United States
Roswell Park Cancer Institute /ID# 269043
Buffalo, New York, United States
Long Island Jewish Medical Center /ID# 269035
New Hyde Park, New York, United States
Columbia University Irving Medical Center /ID# 269033
New York, New York, United States
University of Rochester Medical Center /ID# 269044
Rochester, New York, United States
University of North Carolina Medical Center /ID# 269027
Chapel Hill, North Carolina, United States
Atrium Health Levine Cancer Institute /ID# 269049
Charlotte, North Carolina, United States
The Ohio State University Comprehensive Cancer Center /ID# 269026
Columbus, Ohio, United States
OU Health - Stephenson Cancer Center /ID# 269025
Oklahoma City, Oklahoma, United States
University of Pennsylvania /ID# 269042
Philadelphia, Pennsylvania, United States
West Penn Hospital /ID# 269054
Pittsburgh, Pennsylvania, United States
Women & Infants Hospital /ID# 269032
Providence, Rhode Island, United States
Sanford Cancer Center /ID# 269038
Sioux Falls, South Dakota, United States
Tennessee Oncology Nashville /ID# 269029
Nashville, Tennessee, United States
MD Anderson Houston /ID# 269057
Houston, Texas, United States
University of Virginia /ID# 269053
Charlottesville, Virginia, United States
Monash Health - Monash Medical Centre /ID# 268971
Perth, Western Australia, Australia
Hôpital Vivalia De Libramont /ID# 268979
Libramont-Chevigny, Luxembourg, Belgium
Universitair Ziekenhuis Leuven /ID# 268977
Leuven, Vlaams-Brabant, Belgium
Cross Cancer Institute /ID# 268984
Edmonton, Alberta, Canada
BC Cancer - Kelowna /ID# 268983
Kelowna, British Columbia, Canada
Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 268982
Montreal, Quebec, Canada
Centre Hospitalier Universite De Sherbrooke - Hôtel-Dieu Hospital /ID# 268981
Sherbrooke, Quebec, Canada
Institut de Cancerologie de Ouest /ID# 268997
Saint-Herblain, Pays de la Loire Region, France
Centre Antoine-Lacassagne /ID# 269000
Nice, Provence-Alpes-Côte d'Azur Region, France
Centre Leon Berard /ID# 268993
Lyon, Rhone, France
Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 268996
Pierre-Bénite, Rhone, France
Institut Gustave Roussy /ID# 268994
Villejuif, Île-de-France Region, France
DKD Helios Klinik Wiesbaden /ID# 269011
Wiesbaden, , Germany
Mater Misericordiae University Hospital /ID# 269013
Dublin, , Ireland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 269020
Rome, Roma, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 269018
Ancona, , Italy
Erasmus Medisch Centrum /ID# 269022
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 269023
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 269024
Utrecht, , Netherlands
Institut Català d'Oncologia (ICO) - Badalona /ID# 268990
Badalona, Barcelona, Spain
Hospital Universitario Reina Sofia /ID# 269656
Córdoba, Cordoba, Spain
Hospital Universitario Vall de Hebron /ID# 268986
Barcelona, , Spain
Hospital MD Anderson Cancer Center Madrid /ID# 268991
Madrid, , Spain
Hospital Universitario Ramón y Cajal /ID# 268992
Madrid, , Spain
Hospital Universitario La Paz /ID# 268987
Madrid, , Spain
Hospital Clínico Universitario de Valencia /ID# 268988
Valencia, , Spain
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2023-506842-22
Identifier Type: OTHER
Identifier Source: secondary_id
IMGN151-1001
Identifier Type: -
Identifier Source: org_study_id
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