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 · tracked via the Priya Life Science USA tracker

Sponsor

AbbVie

Phase

Phase 2

Started

2025-07-30

Last updated

2026-10-01

Condition(s) studied

Gynecologic CancersPlatinum-Sensitive Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer (PSOC)

Investigational drug(s) / intervention(s)

IMGN151 →Carboplatin →Bevacizumab →Olaparib →

IMGN151: Intravenous (IV) infusion

Carboplatin: Intravenous (IV) infusion

Bevacizumab: Intravenous (IV) infusion

Olaparib: Oral Tablet

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants With Dose-limiting Toxicities (DLTs) — 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.
Percentage of Participants with Adverse Events (AE) — 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.

Trial sites (21)

Facility	City	Region	Status
Start Los Angeles /ID# 281533	Los Angeles	California	Recruiting
University of Colorado Hospital- Aurora /ID# 278232	Aurora	Colorado	Recruiting
University Of Minnesota /ID# 277850	Minneapolis	Minnesota	Recruiting
Holy Name Medical Center /ID# 279017	Teaneck	New Jersey	Recruiting
SUNY Upstate Medical University - Syracuse /ID# 277305	Syracuse	New York	Recruiting
University of Cincinnati Medical Center. /ID# 278925	Cincinnati	Ohio	Recruiting
University Hospitals Cleveland Medical Center /ID# 279601	Cleveland	Ohio	Recruiting
OU Health - Stephenson Cancer Center /ID# 277656	Oklahoma City	Oklahoma	Recruiting
Providence Portland Medical Center /ID# 277727	Portland	Oregon	Recruiting
Women & Infants Hospital /ID# 277930	Providence	Rhode Island	Recruiting
SCRI Oncology Partners /ID# 279733	Nashville	Tennessee	Recruiting
Texas Oncology-Austin North /ID# 279958	Austin	Texas	Recruiting
Next Virginia /ID# 279684	Fairfax	Virginia	Recruiting
Rabin Medical Center /ID# 279142	Petah Tikva	Central District	Recruiting
The Chaim Sheba Medical Center /ID# 275997	Ramat Gan	Tel Aviv	Recruiting
Tel Aviv Sourasky Medical Center /ID# 275852	Tel Aviv	Tel Aviv	Recruiting
Rambam Health Care Campus- Haifa /ID# 276004	Haifa	Israel	Recruiting
Shaare Zedek Medical Center /ID# 275854	Jerusalem	Israel	Recruiting
Hyogo Cancer Center /ID# 276940	Akashi-shi	Hyōgo	Recruiting
National Cancer Center Hospital /ID# 276715	Chuo-Ku	Tokyo	Recruiting
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 276711	Koto-ku	Tokyo	Recruiting

On this site

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Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer Recruiting

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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 NCT07024784 on ClinicalTrials.gov ↗ ← All trials in the USA