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Endometrial CancerPhase 1NCT05527184

First in Human Study of IMGN151 in Recurrent Gynaecological Cancers

A Phase 1 study testing IMGN151 in people with Endometrial Cancer and High Grade Serous Adenocarcinoma of Ovary, run by AbbVie at 58 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
IMGN151
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
58 sitesin 10 countries
Study dates
11 Jan 2023to Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • 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.
  • 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.
  • Expansion Phase:
  • For Cohort A, recurrent endometrial cancer (high-grade Grade 3 endometrioid or serous histology only) with 1-3 prior lines of therapy.
  • 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.
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  • 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.
  • 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.
  • For Cohort E, cervical cancer including the following histologies: squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma with 1-4 prior lines of therapy.
  • 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.
  • Evaluable lesions
  • Dose-Escalation Phase: Participants may have radiologically evaluable or nonevaluable disease.
  • 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).
  • 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.
  • 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).
  • 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.
  • Participants must have adequate organ and bone marrow function.

Who cannot join

  • Participants with ovarian cancer with histologies including clear cell, mucinous, or borderline ovarian tumor.
  • 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.
  • For Cohort A, participants with endometrial cancer with histologies other than serous or high-grade Grade 3 endometrioid.
  • For Cohort E, participants with cervical cancer with histologies other than adenocarcinoma, squamous cell carcinoma, and adenosquamous carcinoma.
  • 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.
  • Radiation therapy of > 20% of the potential bone marrow
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  • 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.
  • Participants with the following ocular history and/or concurrent disorders:
  • 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
  • History of corneal transplantation
  • Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery
  • Active or chronic clinically significant (≥ Grade 3) corneal disorders (for example, Fuch's dystrophy or neurotrophic keratitis)
  • 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
  • Monocular vision with visual acuity in the worse-seeing eye (worse than 20/200 or visual fields less than 20 degrees)
  • Serious concurrent illness or clinically relevant active infection.
  • A history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
  • Participants with clinically significant cardiac disease.
  • A history of hemorrhagic or ischemic stroke (including transient ischemic attack) within 6 months before enrollment
  • A history of cirrhotic liver disease (Child-Pugh Class B or C)
  • Participants with evidence of pneumonitis on baseline imaging or Participants with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
  • Participants with prior hypersensitivity to monoclonal antibodies (mAb)
  • Females who are pregnant or breastfeeding
  • 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.
  • Untreated or symptomatic central nervous system metastases
  • A history of other malignancy within 3 years before enrollment

Trial locations and contacts

58 sites in 10 countries.

58 sites in 10 countries

United States32 sites

  • UCHSC Anschultz Cancer Pavilion /ID# 269056

    Aurora, Colorado, 80045-2517

  • University of Alabama at Birmingham /ID# 269045

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital /ID# 278119

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute /ID# 269039

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute /ID# 269043

    Buffalo, New York, 14263

  • University of North Carolina Medical Center /ID# 269027

    Chapel Hill, North Carolina, 27514

  • Atrium Health Levine Cancer Institute /ID# 269049

    Charlotte, North Carolina, 28204

  • University of Virginia /ID# 269053

    Charlottesville, Virginia, 22908

  • University of Chicago Medical Center /ID# 269028

    Chicago, Illinois, 60637

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

    Columbus, Ohio, 43210-1240

  • Karmanos Cancer Institute - Detroit /ID# 269052

    Detroit, Michigan, 48201

  • City of Hope National Medical Center /ID# 269036

    Duarte, California, 91010

  • MD Anderson Houston /ID# 269057

    Houston, Texas, 77030-4000

  • University of Mississippi Medical Cancer Center /ID# 269046

    Jackson, Mississippi, 39213

  • AdventHealth Celebration /ID# 269030

    Kissimmee, Florida, 34747

  • Moores Cancer Center /ID# 269040

    La Jolla, California, 92037

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

    Los Angeles, California, 90095

  • Mount Sinai Medical Center /ID# 269050

    Miami, Florida, 33140

  • Miami Cancer Institute at Baptist Health /ID# 269041

    Miami, Florida, 33176

  • Tennessee Oncology Nashville /ID# 269029

    Nashville, Tennessee, 37203

  • Long Island Jewish Medical Center /ID# 269035

    New Hyde Park, New York, 11040

  • Columbia University Irving Medical Center /ID# 269033

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian /ID# 269047

    Newport Beach, California, 92663

  • OU Health - Stephenson Cancer Center /ID# 269025

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania /ID# 269042

    Philadelphia, Pennsylvania, 19104

  • West Penn Hospital /ID# 269054

    Pittsburgh, Pennsylvania, 15224-1722

  • Women & Infants Hospital /ID# 269032

    Providence, Rhode Island, 02905

  • University of Rochester Medical Center /ID# 269044

    Rochester, New York, 14642

  • Florida Cancer Specialists- Sarasota Cattlemen /ID# 269055

    Sarasota, Florida, 34232

  • Sanford Cancer Center /ID# 269038

    Sioux Falls, South Dakota, 57104

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

    St Louis, Missouri, 63130

  • Holy Name Medical Center /ID# 269051

    Teaneck, New Jersey, 07666

Other trials in United States

Spain7 sites

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

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall de Hebron /ID# 268986

    Barcelona, 08035

  • Hospital Universitario Reina Sofia /ID# 269656

    Córdoba, Cordoba, 14004

  • Hospital MD Anderson Cancer Center Madrid /ID# 268991

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal /ID# 268992

    Madrid, 28034

  • Hospital Universitario La Paz /ID# 268987

    Madrid, 28046

  • Hospital Clínico Universitario de Valencia /ID# 268988

    Valencia, 46010

Other trials in Spain

France5 sites

  • Centre Leon Berard /ID# 268993

    Lyon, Rhone, 69373

  • Centre Antoine-Lacassagne /ID# 269000

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

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

    Pierre-Bénite, Rhone, 69310

  • Institut de Cancerologie de Ouest /ID# 268997

    Saint-Herblain, Pays de la Loire Region, 44800

  • Institut Gustave Roussy /ID# 268994

    Villejuif, Île-de-France Region, 94800

Other trials in France

Canada4 sites

  • Cross Cancer Institute /ID# 268984

    Edmonton, Alberta, T6G 1Z2

  • BC Cancer - Kelowna /ID# 268983

    Kelowna, British Columbia, V1Y 5L3

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

    Montreal, Quebec, H2X 3E4

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

    Sherbrooke, Quebec, J1G 2E8

Other trials in Canada

Netherlands3 sites

  • Universitair Medisch Centrum Groningen /ID# 269023

    Groningen, 9713 GR

  • Erasmus Medisch Centrum /ID# 269022

    Rotterdam, South Holland, 3015 CE

  • Universitair Medisch Centrum Utrecht /ID# 269024

    Utrecht, 3584 CX

Other trials in Netherlands

Belgium2 sites

  • Universitair Ziekenhuis Leuven /ID# 268977

    Leuven, Vlaams-Brabant, 3000

  • Hôpital Vivalia De Libramont /ID# 268979

    Libramont-Chevigny, Luxembourg, 6800

Other trials in Belgium

Italy2 sites

  • Azienda Ospedaliero Universitaria delle Marche /ID# 269018

    Ancona, 60020

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

    Rome, Roma, 00168

Other trials in Italy

Australia1 site

  • Monash Health - Monash Medical Centre /ID# 268971

    Perth, Western Australia, 6000

Other trials in Australia

Germany1 site

  • DKD Helios Klinik Wiesbaden /ID# 269011

    Wiesbaden, 65191

Other trials in Germany

Ireland1 site

  • Mater Misericordiae University Hospital /ID# 269013

    Dublin, D07 R2WY

Other trials in Ireland

About this study

Official title: 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.

Read the 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.

Being tested
IMGN151
Keywords
Antibody Drug Conjugate, Platinum-Resistant, Recurrent
Medical subject headings
Endometrial Neoplasms, Fallopian Tube Neoplasms, Uterine Cervical Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMGN151Drug

    IMGN151 is an antibody-drug conjugate (ADC).

Study groups in NCT05527184
Study groupRoleWhat they receive
IMGN151ExperimentalIMGN151 is administered via intravenous (IV) infusion on Day 1 of Cycle 1 every 3-week cycle (Q3W).
Receives: Drug: IMGN151

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Up to approximately 3 years

  2. Number of Participants With Dose-limiting Toxicities (DLTs)

    Measured: Day 21 of Cycle 1 (Cycle length = 3 weeks)

  3. Recommended Dose of IMGN151 Monotherapy

    Measured: Up to approximately 2 years

Secondary outcomes (6)

  1. Maximum Observed Plasma Concentration (Cmax) of IMGN151

    Measured: Up to approximately 3 years

  2. Time to Reach Cmax (Tmax) of IMGN151

    Measured: Up to approximately 3 years

  3. Area Under the Curve From Time 0 to Infinity (AUC0-inf) of IMGN151

    Measured: Up to approximately 3 years

  4. Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs)

    Measured: Up to approximately 3 years

  5. Objective Response Rate (ORR)

    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.

    Measured: Up to approximately 3 years

  6. Duration of Response (DOR)

    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.

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start11 Jan 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05527184
Sponsor's protocol ID
IMGN151-1001
Other IDs
2023-506842-22, 2023
Status last verified
Feb 2026
First submitted
23 Aug 2022
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMGN151 in people with Endometrial Cancer and High Grade Serous Adenocarcinoma of Ovary, run by AbbVie at 58 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Spain, France, Canada, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to approximately 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05527184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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