First in Human Study of IMGN151 in Recurrent Gynaecological Cancers

February 19, 2026 updated by: AbbVie

A Phase 1, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGN151 (Anti-FRα Antibody-drug Conjugate) in Adult Patients With Recurrent Gynaecological Cancers

IIMGN151-1001 is a Phase 1, first in human, open-label dose-escalation, optimization, and expansion study designed to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of IMGN151 in adult participants with recurrent endometrial cancer; recurrent, high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers; or recurrent cervical cancers. All participants will be, in the opinion of the investigator, appropriate for nonplatinum single-agent therapy for their next line of therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants may continue on study drug based on clinical benefit until disease progression, adverse event (AE) requiring discontinuation, withdrawal of consent, physician decision, or other discontinuation criteria are met.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Monash Health - Monash Medical Centre /ID# 268971
  • Belgium
    • Luxembourg
      • Libramont-Chevigny, Luxembourg, Belgium, 6800
        • Hôpital Vivalia De Libramont /ID# 268979
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven /ID# 268977
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute /ID# 268984
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer - Kelowna /ID# 268983
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 268982
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Centre Hospitalier Universite De Sherbrooke - Hôtel-Dieu Hospital /ID# 268981
  • France
    • Pays de la Loire Region
      • Saint-Herblain, Pays de la Loire Region, France, 44800
        • Institut de Cancerologie de Ouest /ID# 268997
    • Provence-Alpes-Côte d'Azur Region
      • Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
        • Centre Antoine-Lacassagne /ID# 269000
    • Rhone
      • Lyon, Rhone, France, 69373
        • Centre Leon Berard /ID# 268993
      • Pierre-Bénite, Rhone, France, 69310
        • Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 268996
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94800
        • Institut Gustave Roussy /ID# 268994
  • Germany
      • Wiesbaden, Germany, 65191
        • DKD Helios Klinik Wiesbaden /ID# 269011
  • Ireland
      • Dublin, Ireland, D07 R2WY
        • Mater Misericordiae University Hospital /ID# 269013
  • Italy
      • Ancona, Italy, 60020
        • Azienda Ospedaliero Universitaria delle Marche /ID# 269018
    • Roma
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 269020
  • Netherlands
      • Groningen, Netherlands, 9713 GR
        • Universitair Medisch Centrum Groningen /ID# 269023
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht /ID# 269024
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 CE
        • Erasmus Medisch Centrum /ID# 269022
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall de Hebron /ID# 268986
      • Madrid, Spain, 28033
        • Hospital MD Anderson Cancer Center Madrid /ID# 268991
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal /ID# 268992
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 268987
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia /ID# 268988
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut Català d'Oncologia (ICO) - Badalona /ID# 268990
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 269656
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham /ID# 269045
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center /ID# 269036
      • La Jolla, California, United States, 92037
        • Moores Cancer Center /ID# 269040
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles Medical Center /ID# 269037
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital Presbyterian /ID# 269047
    • Colorado
      • Aurora, Colorado, United States, 80045-2517
        • UCHSC Anschultz Cancer Pavilion /ID# 269056
    • Florida
      • Kissimmee, Florida, United States, 34747
        • AdventHealth Celebration /ID# 269030
      • Miami, Florida, United States, 33140
        • Mount Sinai Medical Center /ID# 269050
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute at Baptist Health /ID# 269041
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists- Sarasota Cattlemen /ID# 269055
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center /ID# 269028
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital /ID# 278119
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute /ID# 269039
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute - Detroit /ID# 269052
    • Mississippi
      • Jackson, Mississippi, United States, 39213
        • University of Mississippi Medical Cancer Center /ID# 269046
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Washington University School of Medicine - St. Louis /ID# 269048
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center /ID# 269051
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute /ID# 269043
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center /ID# 269035
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center /ID# 269033
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center /ID# 269044
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Medical Center /ID# 269027
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health Levine Cancer Institute /ID# 269049
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • The Ohio State University Comprehensive Cancer Center /ID# 269026
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Health - Stephenson Cancer Center /ID# 269025
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania /ID# 269042
      • Pittsburgh, Pennsylvania, United States, 15224-1722
        • West Penn Hospital /ID# 269054
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital /ID# 269032
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center /ID# 269038
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology Nashville /ID# 269029
    • Texas
      • Houston, Texas, United States, 77030-4000
        • MD Anderson Houston /ID# 269057
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia /ID# 269053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  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 Grade 3 endometrioid or serous histology only) with 1-3 prior lines of therapy.
    2. For Cohort B, a confirmed diagnosis of high-grade serous 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, a confirmed diagnosis of high-grade serous PROC with previous FRα-directed therapy with at least one intervening anticancer therapy between prior FRα-directed therapy other than mirvetuximab soravtansine.
    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. Participants with ovarian cancer with histologies including clear cell, mucinous, or borderline ovarian tumor.

    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 serous or high-grade Grade 3 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. Note: medication management to achieve Grade 1 (asymptomatic) is acceptable.

  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 (including transient ischemic attack) 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). Receipt of prior mirvetuximab soravtansine is excluded for all cohorts.
  15. Untreated or symptomatic central nervous system metastases
  16. A history of other malignancy within 3 years before enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMGN151
IMGN151 is administered via intravenous (IV) infusion on Day 1 of Cycle 1 every 3-week cycle (Q3W).
Drug: IMGN151
IMGN151 is an antibody-drug conjugate (ADC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs)
Time Frame: Day 21 of Cycle 1 (Cycle length = 3 weeks)
Day 21 of Cycle 1 (Cycle length = 3 weeks)
Recommended Dose of IMGN151 Monotherapy
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of IMGN151
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Time to Reach Cmax (Tmax) of IMGN151
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of IMGN151
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 3 years
ORR is defined as the percentage of participants with best response of complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Up to approximately 3 years
Duration of Response (DOR)
Time Frame: Up to approximately 3 years
DOR is defined as the time from initial response (CR or PR) until radiological progressive disease (PD), as assessed by the investigator, or death, whichever occurs first per RECIST v1.1 criteria.
Up to approximately 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine Progression Free Survival (Escalation)
Time Frame: Up to 1 year
PFS (defined as the time from first dose of IMGN151 until investigator-assessed radiological PD or death, whichever occurs first)
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMGN151-1001
  • 2023-506842-22 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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