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
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
2 other identifiers
interventional
377
3 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2025
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2025
CompletedFirst Posted
Study publicly available on registry
June 17, 2025
CompletedStudy Start
First participant enrolled
July 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
June 2, 2026
May 1, 2026
2.4 years
June 9, 2025
May 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Dose-limiting Toxicities (DLTs)
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.
Up to approximately 3 years
Percentage of Participants with Adverse Events (AE)
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.
Up to approximately 3 years
Secondary Outcomes (3)
Objective Response (OR)
Up to approximately 3 years
Duration of response (DOR)
Up to approximately 3 years
Progression-free survival (PFS)
Up to approximately 3 years
Study Arms (6)
Arm A: IMGN151 + Carboplatin (For PSOC)
EXPERIMENTALParticipants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle.
Arm B: IMGN151 + Olaparib (For PSOC)
EXPERIMENTALParticipants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle.
Arm C: IMGN151 + Bevacizumab (For PSOC or PROC)
EXPERIMENTALParticipants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle.
Arm D: IMGN151 Monotherapy (For PSOC)
EXPERIMENTALParticipants will receive IMGN151 Day 1 of a 21-day cycle.
Arm E: IMGN151 Monotherapy (For PROC in China)
EXPERIMENTALParticipants will receive IMGN151 Day 1 of a 21-day cycle.
Arm F: IMGN151 Monotherapy (For PROC in Japan)
EXPERIMENTALParticipants will receive IMGN151 Day 1 of a 21-day cycle.
Interventions
Intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- GOG Foundationcollaborator
Study Sites (16)
Holy Name Medical Center /ID# 279017
Teaneck, New Jersey, 07666, United States
University of Cincinnati Medical Center. /ID# 278925
Cincinnati, Ohio, 45219, United States
OU Health - Stephenson Cancer Center /ID# 277656
Oklahoma City, Oklahoma, 73104, United States
Providence Portland Medical Center /ID# 277727
Portland, Oregon, 97213, United States
Women & Infants Hospital /ID# 277930
Providence, Rhode Island, 02905, United States
SCRI Oncology Partners /ID# 279733
Nashville, Tennessee, 37203, United States
Texas Oncology-Austin North /ID# 279958
Austin, Texas, 78758, United States
Next Virginia /ID# 279684
Fairfax, Virginia, 22031, United States
Rabin Medical Center /ID# 279142
Petah Tikva, Central District, 4941492, Israel
The Chaim Sheba Medical Center /ID# 275997
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 275852
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus- Haifa /ID# 276004
Haifa, 3109601, Israel
Shaare Zedek Medical Center /ID# 275854
Jerusalem, 9103102, Israel
Hyogo Cancer Center /ID# 276940
Akashi-shi, Hyōgo, 673-8558, Japan
National Cancer Center Hospital /ID# 276715
Chuo-Ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR /ID# 276711
Koto-ku, Tokyo, 135-8550, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2025
First Posted
June 17, 2025
Study Start
July 30, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.