First in Human Study of IMGN151 in Recurrent Gynaecological Cancers

NCT05527184 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: IMGN151-10012023-506842-22
• Study Type: interventional
• Target: 256
• Locations: 10 countries
• Sites: 58

Brief 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, 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.

Conditions

Endometrial Cancer; High Grade Serous Adenocarcinoma of Ovary; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Cervical Cancer

Keywords

Antibody Drug Conjugate; Platinum-Resistant; Recurrent

Outcome Measures

Primary Outcomes (3)

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

  Up to approximately 3 years

• Number of Participants With Dose-limiting Toxicities (DLTs)

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

• Recommended Dose of IMGN151 Monotherapy

  Up to approximately 2 years

Secondary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) of IMGN151

  Up to approximately 3 years

• Time to Reach Cmax (Tmax) of IMGN151

  Up to approximately 3 years

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

  Up to approximately 3 years

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

  Up to approximately 3 years

• Objective Response Rate (ORR)

  Up to approximately 3 years

Study Arms (1)

IMGN151

EXPERIMENTAL

IMGN151 is administered via intravenous (IV) infusion on Day 1 of Cycle 1 every 3-week cycle (Q3W).

Drug: IMGN151

Interventions

IMGN151 DRUG

IMGN151 is an antibody-drug conjugate (ADC).

IMGN151

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (58)

University of Alabama at Birmingham /ID# 269045

Birmingham, Alabama, 35233, United States

Location

City of Hope National Medical Center /ID# 269036

Duarte, California, 91010, United States

Location

Moores Cancer Center /ID# 269040

La Jolla, California, 92037, United States

Location

University of California Los Angeles Medical Center /ID# 269037

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian /ID# 269047

Newport Beach, California, 92663, United States

Location

UCHSC Anschultz Cancer Pavilion /ID# 269056

Aurora, Colorado, 80045-2517, United States

Location

AdventHealth Celebration /ID# 269030

Kissimmee, Florida, 34747, United States

Location

Mount Sinai Medical Center /ID# 269050

Miami, Florida, 33140, United States

Location

Miami Cancer Institute at Baptist Health /ID# 269041

Miami, Florida, 33176, United States

Location

Florida Cancer Specialists- Sarasota Cattlemen /ID# 269055

Sarasota, Florida, 34232, United States

Location

University of Chicago Medical Center /ID# 269028

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital /ID# 278119

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute /ID# 269039

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute - Detroit /ID# 269052

Detroit, Michigan, 48201, United States

Location

University of Mississippi Medical Cancer Center /ID# 269046

Jackson, Mississippi, 39213, United States

Location

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

St Louis, Missouri, 63130, United States

Location

Holy Name Medical Center /ID# 269051

Teaneck, New Jersey, 07666, United States

Location

Roswell Park Cancer Institute /ID# 269043

Buffalo, New York, 14263, United States

Location

Long Island Jewish Medical Center /ID# 269035

New Hyde Park, New York, 11040, United States

Location

Columbia University Irving Medical Center /ID# 269033

New York, New York, 10032, United States

Location

University of Rochester Medical Center /ID# 269044

Rochester, New York, 14642, United States

Location

University of North Carolina Medical Center /ID# 269027

Chapel Hill, North Carolina, 27514, United States

Location

Atrium Health Levine Cancer Institute /ID# 269049

Charlotte, North Carolina, 28204, United States

Location

The Ohio State University Comprehensive Cancer Center /ID# 269026

Columbus, Ohio, 43210-1240, United States

Location

OU Health - Stephenson Cancer Center /ID# 269025

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania /ID# 269042

Philadelphia, Pennsylvania, 19104, United States

Location

West Penn Hospital /ID# 269054

Pittsburgh, Pennsylvania, 15224-1722, United States

Location

Women & Infants Hospital /ID# 269032

Providence, Rhode Island, 02905, United States

Location

Sanford Cancer Center /ID# 269038

Sioux Falls, South Dakota, 57104, United States

Location

Tennessee Oncology Nashville /ID# 269029

Nashville, Tennessee, 37203, United States

Location

MD Anderson Houston /ID# 269057

Houston, Texas, 77030-4000, United States

Location

University of Virginia /ID# 269053

Charlottesville, Virginia, 22908, United States

Location

Monash Health - Monash Medical Centre /ID# 268971

Perth, Western Australia, 6000, Australia

Location

Hôpital Vivalia De Libramont /ID# 268979

Libramont-Chevigny, Luxembourg, 6800, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 268977

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Cross Cancer Institute /ID# 268984

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer - Kelowna /ID# 268983

Kelowna, British Columbia, V1Y 5L3, Canada

Location

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

Montreal, Quebec, H2X 3E4, Canada

Location

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

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Institut de Cancerologie de Ouest /ID# 268997

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

Location

Centre Antoine-Lacassagne /ID# 269000

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

Location

Centre Leon Berard /ID# 268993

Lyon, Rhone, 69373, France

Location

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

Pierre-Bénite, Rhone, 69310, France

Location

Institut Gustave Roussy /ID# 268994

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

Location

DKD Helios Klinik Wiesbaden /ID# 269011

Wiesbaden, 65191, Germany

Location

Mater Misericordiae University Hospital /ID# 269013

Dublin, D07 R2WY, Ireland

Location

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

Rome, Roma, 00168, Italy

Location

Azienda Ospedaliero Universitaria delle Marche /ID# 269018

Ancona, 60020, Italy

Location

Erasmus Medisch Centrum /ID# 269022

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 269023

Groningen, 9713 GR, Netherlands

Location

Universitair Medisch Centrum Utrecht /ID# 269024

Utrecht, 3584 CX, Netherlands

Location

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

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Reina Sofia /ID# 269656

Córdoba, Cordoba, 14004, Spain

Location

Hospital Universitario Vall de Hebron /ID# 268986

Barcelona, 08035, Spain

Location

Hospital MD Anderson Cancer Center Madrid /ID# 268991

Madrid, 28033, Spain

Location

Hospital Universitario Ramón y Cajal /ID# 268992

Madrid, 28034, Spain

Location

Hospital Universitario La Paz /ID# 268987

Madrid, 28046, Spain

Location

Hospital Clínico Universitario de Valencia /ID# 268988

Valencia, 46010, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Endometrial Neoplasms; Fallopian Tube Neoplasms; Uterine Cervical Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fallopian Tube Diseases; Adnexal Diseases; Uterine Cervical Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 2, 2022
• Study Start: January 11, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (32); CA (4); IT (2); ES (7); BE (2); FR (5); DE (1); NL (3); IE (1)