> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-change-in-disease-activity-and-adverse-ce5d9542-23f2-4d8f-aaf4-b5f23f3dc649 > Record changed: 2026-10-13 # A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies NCT07024784 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) Participants 377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) Start date 2025-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) Number of sites 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Title and summary **Summary** Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult participants with gynecologic cancers. IMGN151 is an investigational drug being developed for the treatment of gynecologic cancers. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 377 participants with gynecologic cancers will be enrolled in the study at approximately 50 sites worldwide. Participants will receive intravenous infusions of IMGN151 as monotherapy or in combination with anti-cancer therapies according to their assigned study arm. In Arm A, participants will receive IMGN151 in combination with carboplatin on Day 1 of each cycle. In Arm B, participants will receive IMGN151 in combination with olaparib, twice a day (BID) on Day 1 of each cycle. In Arm C, participants will receive IMGN151 in combination with bevacizumab on Day 1 of each cycle. In Arm D, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm E, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm F, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. The total study duration will be approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Short title** A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Official title** A Phase 1b Dose Escalation and Expansion Study of IMGN151 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Subjects With Gynecologic Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Dates **Completion date** 2028-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **First posted** 2025-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Registry last updated** 2026-06-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Primary completion date** 2028-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Start date** 2025-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Size and sites **Participants** 377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Planned participants** 377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Number of sites** 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Identifiers **Registry ID** NCT07024784 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **ClinicalTrials.gov ID** NCT07024784 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Outcomes ### Primary outcomes 1. Number of Participants With Dose-limiting Toxicities (DLTs) Timeframe: Up to approximately 3 years Dose limiting toxicities (DLTs) of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications. 2. Percentage of Participants with Adverse Events (AE) Timeframe: Up to approximately 3 years An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. ### Secondary outcomes 1. Objective Response (OR) Timeframe: Up to approximately 3 years Defined as achieving confirmed response (complete response \\\[CR\\\] + partial response \\\[PR\\\]) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. 2. Duration of response (DOR) Timeframe: Up to approximately 3 years Defined as the time from initial response of CR or PR until investigator assessed radiographical PD per RECIST v1.1 or death of any cause, whichever occurs first. 3. Progression-free survival (PFS) Timeframe: Up to approximately 3 years Defined as the time from the randomization date for randomized phase or the first dose of study treatment for non-randomized phase until investigator-assessed radiographical PD per RECIST v1.1 or death of any cause, whichever occurs first. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - ECOG performance status of 0 or 1 - Participants (except for platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer (PSOC) participants without disease progression after platinum combination standard of care therapy in Arms B and D) will have ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiographically measured by the investigator). - Participants will have high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC). - Participant has completed prior therapy within the specified times below: - Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of IMGN151. - Focal radiation completed ≥ 2 weeks prior to the first dose of study treatment. ### Exclusion criteria - Participants with ovarian cancer with histologies including: endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, as well a low-grade or borderline ovarian tumor. - History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study treatment. - Prior treatment with FRα-targeting therapy. - Prior wide-field radiotherapy affecting more than 20% of the bone marrow. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Sites - Holy Name Medical Center /ID# 279017Teaneck, United StatesRecruiting - University of Cincinnati Medical Center. /ID# 278925Cincinnati, United StatesRecruiting - OU Health - Stephenson Cancer Center /ID# 277656Oklahoma City, United StatesRecruiting - Providence Portland Medical Center /ID# 277727Portland, United StatesRecruiting - Women & Infants Hospital /ID# 277930Providence, United StatesRecruiting - SCRI Oncology Partners /ID# 279733Nashville, United StatesRecruiting - Texas Oncology-Austin North /ID# 279958Austin, United StatesRecruiting - Next Virginia /ID# 279684Fairfax, United StatesRecruiting - Rabin Medical Center /ID# 279142Petah Tikva, IsraelRecruiting - The Chaim Sheba Medical Center /ID# 275997Ramat Gan, IsraelRecruiting - Tel Aviv Sourasky Medical Center /ID# 275852Tel Aviv, IsraelRecruiting - Rambam Health Care Campus- Haifa /ID# 276004Haifa, IsraelRecruiting - Shaare Zedek Medical Center /ID# 275854Jerusalem, IsraelRecruiting - Hyogo Cancer Center /ID# 276940Akashi-shi, JapanRecruiting - National Cancer Center Hospital /ID# 276715Chuo-Ku, JapanRecruiting - The Cancer Institute Hospital Of JFCR /ID# 276711Koto-ku, JapanRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## References ### Other registry identifiers - GOG-3124 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07024784) ## Related records ### Drugs (4) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Olaparib](https://trialight.com/data/asset/olaparib-3421b73f-1a4f-4337-b6f3-de5feeb57108.md) - [Opugotamig olatansine](https://trialight.com/data/asset/opugotamig-olatansine-716e7ad2-2f04-44da-b703-6cbfeb18fd67.md) ### Collaborators (1) - GOG Foundation ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (4) - [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) - [Female reproductive organ cancer](https://trialight.com/data/condition/female-reproductive-organ-cancer-1207d84e-931f-51b6-90d9-6b2135cdebbb.md) Primary condition - [Primary peritoneal carcinoma](https://trialight.com/data/condition/primary-peritoneal-carcinoma-9bb0e4b4-cb5a-5d56-8331-331c250af14d.md) ### Targets (4) - [PARP1](https://trialight.com/data/target/parp1-78c558f2-1477-56b9-9f9f-c1e925a07421.md) - [PARP2](https://trialight.com/data/target/parp2-2551f72f-f11f-5c9e-9253-3f01dfbad379.md) - [PARP3](https://trialight.com/data/target/parp3-d8123f64-d038-5fd1-9927-4abad8f9d28d.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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