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New Antibody-Drug conjugate takes aim at Hard-to-Treat gynaecological cancers

NCT ID NCT05527184

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called IMGN151 in 256 adults with recurrent gynaecological cancers, including ovarian, endometrial, and cervical cancers. The drug is an antibody-drug conjugate designed to deliver a cancer-killing agent directly to cells that have a specific marker (folate receptor alpha). The study's main goals are to check safety, find the right dose, and get an early look at whether the drug can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMGN151 (an antibody-drug conjugate that targets folate receptor alpha on cancer cells)
What this could lead to
If it works, this could lead to a new treatment option for people with recurrent gynaecological cancers that have not responded to standard therapies.
What could go wrong
This is a very early Phase 1 trial, so the main goals are safety and dosing, not yet proving effectiveness. The drug may cause side effects or fail to shrink tumors in later studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

256 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma endometrial cancer endometrial carcinoma endometrium neoplasm fallopian tube cancer fallopian tube neoplasm ovarian serous adenocarcinoma primary peritoneal carcinoma Recurrence Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer Endometrial cancer Fallopian tube cancer High grade serous adenocarcinoma of ovary Primary peritoneal carcinoma

Contacts and locations

Locations

  • AdventHealth Celebration /ID# 269030

    Kissimmee, Florida, 34747, United States

  • Atrium Health Levine Cancer Institute /ID# 269049

    Charlotte, North Carolina, 28204, United States

  • Azienda Ospedaliero Universitaria delle Marche /ID# 269018

    Ancona, 60020, Italy

  • BC Cancer - Kelowna /ID# 268983

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Centre Antoine-Lacassagne /ID# 269000

    Nice, Provence-Alpes-Côte d'Azur Region, 06189, France

  • Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 268982

    Montreal, Quebec, H2X 3E4, Canada

  • Centre Hospitalier Universite De Sherbrooke - Hôtel-Dieu Hospital /ID# 268981

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Centre Leon Berard /ID# 268993

    Lyon, Rhone, 69373, France

  • City of Hope National Medical Center /ID# 269036

    Duarte, California, 91010, United States

  • Columbia University Irving Medical Center /ID# 269033

    New York, New York, 10032, United States

  • Cross Cancer Institute /ID# 268984

    Edmonton, Alberta, T6G 1Z2, Canada

  • DKD Helios Klinik Wiesbaden /ID# 269011

    Wiesbaden, 65191, Germany

  • Dana-Farber Cancer Institute /ID# 269039

    Boston, Massachusetts, 02215, United States

  • Erasmus Medisch Centrum /ID# 269022

    Rotterdam, South Holland, 3015 CE, Netherlands

  • Florida Cancer Specialists- Sarasota Cattlemen /ID# 269055

    Sarasota, Florida, 34232, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 269020

    Rome, Roma, 00168, Italy

  • Hoag Memorial Hospital Presbyterian /ID# 269047

    Newport Beach, California, 92663, United States

  • Holy Name Medical Center /ID# 269051

    Teaneck, New Jersey, 07666, United States

  • Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud /ID# 268996

    Pierre-Bénite, Rhone, 69310, France

  • Hospital Clínico Universitario de Valencia /ID# 268988

    Valencia, 46010, Spain

  • Hospital MD Anderson Cancer Center Madrid /ID# 268991

    Madrid, 28033, Spain

  • Hospital Universitario La Paz /ID# 268987

    Madrid, 28046, Spain

  • Hospital Universitario Ramón y Cajal /ID# 268992

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofia /ID# 269656

    Córdoba, Cordoba, 14004, Spain

  • Hospital Universitario Vall de Hebron /ID# 268986

    Barcelona, 08035, Spain

  • Hôpital Vivalia De Libramont /ID# 268979

    Libramont-Chevigny, Luxembourg, 6800, Belgium

  • Institut Català d'Oncologia (ICO) - Badalona /ID# 268990

    Badalona, Barcelona, 08916, Spain

  • Institut Gustave Roussy /ID# 268994

    Villejuif, Île-de-France Region, 94800, France

  • Institut de Cancerologie de Ouest /ID# 268997

    Saint-Herblain, Pays de la Loire Region, 44800, France

  • Karmanos Cancer Institute - Detroit /ID# 269052

    Detroit, Michigan, 48201, United States

  • Long Island Jewish Medical Center /ID# 269035

    New Hyde Park, New York, 11040, United States

  • MD Anderson Houston /ID# 269057

    Houston, Texas, 77030-4000, United States

  • Massachusetts General Hospital /ID# 278119

    Boston, Massachusetts, 02114, United States

  • Mater Misericordiae University Hospital /ID# 269013

    Dublin, D07 R2WY, Ireland

  • Miami Cancer Institute at Baptist Health /ID# 269041

    Miami, Florida, 33176, United States

  • Monash Health - Monash Medical Centre /ID# 268971

    Perth, Western Australia, 6000, Australia

  • Moores Cancer Center /ID# 269040

    La Jolla, California, 92037, United States

  • Mount Sinai Medical Center /ID# 269050

    Miami, Florida, 33140, United States

  • OU Health - Stephenson Cancer Center /ID# 269025

    Oklahoma City, Oklahoma, 73104, United States

  • Roswell Park Cancer Institute /ID# 269043

    Buffalo, New York, 14263, United States

  • Sanford Cancer Center /ID# 269038

    Sioux Falls, South Dakota, 57104, United States

  • Tennessee Oncology Nashville /ID# 269029

    Nashville, Tennessee, 37203, United States

  • The Ohio State University Comprehensive Cancer Center /ID# 269026

    Columbus, Ohio, 43210-1240, United States

  • UCHSC Anschultz Cancer Pavilion /ID# 269056

    Aurora, Colorado, 80045-2517, United States

  • Universitair Medisch Centrum Groningen /ID# 269023

    Groningen, 9713 GR, Netherlands

  • Universitair Medisch Centrum Utrecht /ID# 269024

    Utrecht, 3584 CX, Netherlands

  • Universitair Ziekenhuis Leuven /ID# 268977

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University of Alabama at Birmingham /ID# 269045

    Birmingham, Alabama, 35233, United States

  • University of California Los Angeles Medical Center /ID# 269037

    Los Angeles, California, 90095, United States

  • University of Chicago Medical Center /ID# 269028

    Chicago, Illinois, 60637, United States

  • University of Mississippi Medical Cancer Center /ID# 269046

    Jackson, Mississippi, 39213, United States

  • University of North Carolina Medical Center /ID# 269027

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania /ID# 269042

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center /ID# 269044

    Rochester, New York, 14642, United States

  • University of Virginia /ID# 269053

    Charlottesville, Virginia, 22908, United States

  • Washington University School of Medicine - St. Louis /ID# 269048

    St Louis, Missouri, 63130, United States

  • West Penn Hospital /ID# 269054

    Pittsburgh, Pennsylvania, 15224-1722, United States

  • Women & Infants Hospital /ID# 269032

    Providence, Rhode Island, 02905, United States

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