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

{ "IMGN151 for Gynecologic Cancers", "This study is looking at a new investigational drug called IMGN151 for adults with gynecologic cancers. Researchers want to see how safe IMGN151 is and how well people tolerate it, both when given alone and when combined with other cancer treatments like Carboplatin, Bevacizumab, or Olaparib. You would receive IMGN151 through an intravenous (IV) infusion. The study will enroll about 377 participants and aims to understand how many people experience side effects and how severe they are over approximately three years. This study is for women aged 18 and older with gynecologic cancers, including platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer.", "design": "This is an interventional study involving approximately 377 participants who will be placed into one of four treatment groups. Each group receives a different treatment combination.", "commitments": "Participants will receive intravenous infusions of IMGN151, either alone or with other anti-cancer therapies, according to their assigned group.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be monitored for side effects and dose-limiting toxicities for up to approximately three years.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

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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

Recruiting

PHASE2Ages 18+InterventionalTreatment

AbbVie

~377 participants

Updated 2026-06-02 on ClinicalTrials.gov

What's tested:IMGN151CarboplatinBevacizumabOlaparib

At a glance

Recruiting sites

16 of 16 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of Participants With Dose-limiting Toxicities (DLTs)

Measured over Up to approximately 3 years

+1 more outcome measured

Conditions

Gynecologic Cancers

Platinum-Sensitive Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Cancer (PSOC)

Where it's being run

16 sites across 13 states

Tel Aviv2

Israel2

Tokyo2

New Jersey1

Ohio1

Oklahoma1

Oregon1

Rhode Island1

Study leadership

ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER

[email protected]

844-663-3742

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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.

Trialytics