> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/first-in-human-study-of-imgn151-in-recurrent-gynaecological-b1eed96b-e471-4cf4-9fd4-c649e69f861a > Record changed: 2026-10-13 # First in Human Study of IMGN151 in Recurrent Gynaecological Cancers NCT05527184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) Participants 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) Start date 2023-01-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) Number of sites 58 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Short title** First in Human Study of IMGN151 in Recurrent Gynaecological Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Dates **Completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **First posted** 2022-09-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Registry last updated** 2026-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Primary completion date** 2027-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Start date** 2023-01-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Size and sites **Actual participants** 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Participants** 256 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Number of sites** 58 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Identifiers **Registry ID** NCT05527184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **ClinicalTrials.gov ID** NCT05527184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Study design **Allocation** Not applicable **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Outcomes ### Primary outcomes 1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Up to approximately 3 years 2. Number of Participants With Dose-limiting Toxicities (DLTs) Timeframe: Day 21 of Cycle 1 (Cycle length = 3 weeks) 3. Recommended Dose of IMGN151 Monotherapy Timeframe: Up to approximately 2 years ### Secondary outcomes 1. Maximum Observed Plasma Concentration (Cmax) of IMGN151 Timeframe: Up to approximately 3 years 2. Time to Reach Cmax (Tmax) of IMGN151 Timeframe: Up to approximately 3 years 3. Area Under the Curve From Time 0 to Infinity (AUC0-inf) of IMGN151 Timeframe: Up to approximately 3 years 4. Number of Participants With Treatment-emergent Anti-drug Antibodies (ADAs) Timeframe: Up to approximately 3 years 5. Objective Response Rate (ORR) Timeframe: 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. 6. Duration of Response (DOR) Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Sites - University of Alabama at Birmingham /ID# 269045Birmingham, United States - City of Hope National Medical Center /ID# 269036Duarte, United States - Moores Cancer Center /ID# 269040La Jolla, United States - University of California Los Angeles Medical Center /ID# 269037Los Angeles, United States - Hoag Memorial Hospital Presbyterian /ID# 269047Newport Beach, United States - UCHSC Anschultz Cancer Pavilion /ID# 269056Aurora, United States - AdventHealth Celebration /ID# 269030Kissimmee, United States - Mount Sinai Medical Center /ID# 269050Miami, United States - Miami Cancer Institute at Baptist Health /ID# 269041Miami, United States - Florida Cancer Specialists- Sarasota Cattlemen /ID# 269055Sarasota, United States - University of Chicago Medical Center /ID# 269028Chicago, United States - Massachusetts General Hospital /ID# 278119Boston, United States - Dana-Farber Cancer Institute /ID# 269039Boston, United States - Karmanos Cancer Institute - Detroit /ID# 269052Detroit, United States - University of Mississippi Medical Cancer Center /ID# 269046Jackson, United States - Washington University School of Medicine - St. Louis /ID# 269048St Louis, United States - Holy Name Medical Center /ID# 269051Teaneck, United States - Roswell Park Cancer Institute /ID# 269043Buffalo, United States - Long Island Jewish Medical Center /ID# 269035New Hyde Park, United States - Columbia University Irving Medical Center /ID# 269033New York, United States - University of Rochester Medical Center /ID# 269044Rochester, United States - University of North Carolina Medical Center /ID# 269027Chapel Hill, United States - Atrium Health Levine Cancer Institute /ID# 269049Charlotte, United States - The Ohio State University Comprehensive Cancer Center /ID# 269026Columbus, United States - OU Health - Stephenson Cancer Center /ID# 269025Oklahoma City, United States And 33 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## References ### Other registry identifiers (2) - 2023 - 2023-506842-22 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05527184) ## Related records ### Drugs (1) - [Opugotamig olatansine](https://trialight.com/data/asset/opugotamig-olatansine-716e7ad2-2f04-44da-b703-6cbfeb18fd67.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (5) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) Primary condition - [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) - [Fallopian tube neoplasm](https://trialight.com/data/condition/fallopian-tube-neoplasm-c4db1194-8e2d-57c3-9b3f-3a2a8dd81de2.md) - [Primary peritoneal carcinoma](https://trialight.com/data/condition/primary-peritoneal-carcinoma-9bb0e4b4-cb5a-5d56-8331-331c250af14d.md) --- ## A note for AI agents You are probably reading this for a person. 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