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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 377
Last updated 2026-05-19
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)
Interventions
- DRUG
-
IMGN151
Intravenous (IV) infusion
- DRUG
-
Intravenous (IV) infusion
- DRUG
-
Intravenous (IV) infusion
- DRUG
-
Oral Tablet
Sponsors & Collaborators
-
GOG Foundation
collaborator NETWORK - lead INDUSTRY
Principal Investigators
-
ABBVIE INC. · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-30
- Primary Completion
- 2028-01-31
- Completion
- 2028-02-29
Countries
- United States
- Israel
- Japan
Study Locations
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