🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in Ireland / NCT05527184
Active, not recruiting Phase 1

First in Human Study of IMGN151 in Recurrent Gynaecological Cancers

NCT05527184 · tracked via the Priya Life Science Ireland tracker
Sponsor
AbbVie
Phase
Phase 1
Started
2023-01-11
Last updated
2026-02-20

Condition(s) studied

Endometrial CancerHigh Grade Serous Adenocarcinoma of OvaryPrimary Peritoneal CarcinomaFallopian Tube CancerCervical Cancer

Investigational drug(s) / intervention(s)

IMGN151

IMGN151: IMGN151 is an antibody-drug conjugate (ADC).

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
University of Alabama at Birmingham /ID# 269045 Birmingham Alabama
City of Hope National Medical Center /ID# 269036 Duarte California
Moores Cancer Center /ID# 269040 La Jolla California
University of California Los Angeles Medical Center /ID# 269037 Los Angeles California
Hoag Memorial Hospital Presbyterian /ID# 269047 Newport Beach California
UCHSC Anschultz Cancer Pavilion /ID# 269056 Aurora Colorado
AdventHealth Celebration /ID# 269030 Kissimmee Florida
Mount Sinai Medical Center /ID# 269050 Miami Florida
Miami Cancer Institute at Baptist Health /ID# 269041 Miami Florida
Florida Cancer Specialists- Sarasota Cattlemen /ID# 269055 Sarasota Florida
University of Chicago Medical Center /ID# 269028 Chicago Illinois
Massachusetts General Hospital /ID# 278119 Boston Massachusetts
Dana-Farber Cancer Institute /ID# 269039 Boston Massachusetts
Karmanos Cancer Institute - Detroit /ID# 269052 Detroit Michigan
University of Mississippi Medical Cancer Center /ID# 269046 Jackson Mississippi
Washington University School of Medicine - St. Louis /ID# 269048 St Louis Missouri
Holy Name Medical Center /ID# 269051 Teaneck New Jersey
Roswell Park Cancer Institute /ID# 269043 Buffalo New York
Long Island Jewish Medical Center /ID# 269035 New Hyde Park New York
Columbia University Irving Medical Center /ID# 269033 New York New York
University of Rochester Medical Center /ID# 269044 Rochester New York
University of North Carolina Medical Center /ID# 269027 Chapel Hill North Carolina
Atrium Health Levine Cancer Institute /ID# 269049 Charlotte North Carolina
The Ohio State University Comprehensive Cancer Center /ID# 269026 Columbus Ohio
OU Health - Stephenson Cancer Center /ID# 269025 Oklahoma City Oklahoma
University of Pennsylvania /ID# 269042 Philadelphia Pennsylvania
West Penn Hospital /ID# 269054 Pittsburgh Pennsylvania
Women & Infants Hospital /ID# 269032 Providence Rhode Island
Sanford Cancer Center /ID# 269038 Sioux Falls South Dakota
Tennessee Oncology Nashville /ID# 269029 Nashville Tennessee
MD Anderson Houston /ID# 269057 Houston Texas
University of Virginia /ID# 269053 Charlottesville Virginia
Monash Health - Monash Medical Centre /ID# 268971 Perth Western Australia
Hôpital Vivalia De Libramont /ID# 268979 Libramont-Chevigny Luxembourg
Universitair Ziekenhuis Leuven /ID# 268977 Leuven Vlaams-Brabant
Cross Cancer Institute /ID# 268984 Edmonton Alberta
BC Cancer - Kelowna /ID# 268983 Kelowna British Columbia
Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 268982 Montreal Quebec
Centre Hospitalier Universite De Sherbrooke - Hôtel-Dieu Hospital /ID# 268981 Sherbrooke Quebec
Institut de Cancerologie de Ouest /ID# 268997 Saint-Herblain Pays de la Loire Region

+ 18 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05527184 on ClinicalTrials.gov ↗ ← All trials in Ireland