Recruiting

Phase 2

IMGN151, Carboplatin, Olaparib, BevacizumabA 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

Sponsor:

AbbVie

Code:

NCT07024784

Conditions

Gynecologic Cancers

Platinum-Sensitive Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer (PSOC)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IMGN151

Carboplatin

Bevacizumab

Olaparib

Study Details

Brief 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.

Conditions

Gynecologic Cancers

Platinum-Sensitive Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer (PSOC)

Study ID

NCT07024784

Start date

Jul 30, 2025

Status verified date

May, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

377 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: IMGN151 + Carboplatin (For PSOC)

Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle.

experimental: Arm B: IMGN151 + Olaparib (For PSOC)

Participants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle.

experimental: Arm C: IMGN151 + Bevacizumab (For PSOC or PROC)

Participants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle.

experimental: Arm D: IMGN151 Monotherapy (For PSOC)

Participants will receive IMGN151 Day 1 of a 21-day cycle.

experimental: Arm E: IMGN151 Monotherapy (For PROC in China)

Participants will receive IMGN151 Day 1 of a 21-day cycle.

experimental: Arm F: IMGN151 Monotherapy (For PROC in Japan)

Participants will receive IMGN151 Day 1 of a 21-day cycle.

Interventions

IMGN151

Intravenous (IV) infusion

Carboplatin

Intravenous (IV) infusion

Bevacizumab

Intravenous (IV) infusion

Olaparib

Oral Tablet

Primary outcome measure

Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Up to approximately 3 years ]
Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Holy Name Medical Center /ID# 279017

Recruiting

Teaneck, New Jersey, United States, 07666

University of Cincinnati Medical Center. /ID# 278925

Recruiting

Cincinnati, Ohio, United States, 45219

OU Health - Stephenson Cancer Center /ID# 277656

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Providence Portland Medical Center /ID# 277727

Recruiting

Portland, Oregon, United States, 97213

Women & Infants Hospital /ID# 277930

Recruiting

Providence, Rhode Island, United States, 02905

SCRI Oncology Partners /ID# 279733

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology-Austin North /ID# 279958

Recruiting

Austin, Texas, United States, 78758

Next Virginia /ID# 279684

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

AbbVie

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

Gynecologic Cancers
Platinum-Sensitive Ovarian Cancer
Platinum-Resistant Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer (PSOC)
Cancer
IMGN151

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-02.