Actively Recruiting
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
Led by AbbVie · Updated on 2026-04-06
377
Participants Needed
14
Research Sites
130 weeks
Total Duration
On this page
Sponsors
A
AbbVie
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
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ECOG performance status of 0 or 1
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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).
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Participants will have high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC).
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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 will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Holy Name Medical Center /ID# 279017
Teaneck, New Jersey, United States, 07666
Actively Recruiting
2
Providence Portland Medical Center /ID# 277727
Portland, Oregon, United States, 97213
Actively Recruiting
3
Women & Infants Hospital /ID# 277930
Providence, Rhode Island, United States, 02905
Actively Recruiting
4
SCRI Oncology Partners /ID# 279733
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
Texas Oncology-Austin North /ID# 279958
Austin, Texas, United States, 78758
Actively Recruiting
6
Next Virginia /ID# 279684
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
Rabin Medical Center /ID# 279142
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
8
The Chaim Sheba Medical Center /ID# 275997
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
9
Tel Aviv Sourasky Medical Center /ID# 275852
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
10
Rambam Health Care Campus- Haifa /ID# 276004
Haifa, Israel, 3525408
Actively Recruiting
11
Shaare Zedek Medical Center /ID# 275854
Jerusalem, Israel, 9103102
Actively Recruiting
12
Hyogo Cancer Center /ID# 276940
Akashi-shi, Hyōgo, Japan, 673-8558
Actively Recruiting
13
National Cancer Center Hospital /ID# 276715
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
14
The Cancer Institute Hospital Of JFCR /ID# 276711
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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