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NCT07024784RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
377 (estimated)
First submitted
9 Jun 2025
Start date
30 Jul 2025
Primary completion date
31 Jan 2028
Lead sponsor
AbbVie
NCT number
NCT07024784

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 377
  • From 30 Jul 2025 to the primary completion date, 31 Jan 2028
  • 21 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with FRα-targeting therapy.
  • Prior wide-field radiotherapy affecting more than 20% of the bone marrow.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rambam Health Care Campus- Haifa /ID# 276004
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Shaare Zedek Medical Center /ID# 275854
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JerusalemIsraelRecruiting
Rabin Medical Center /ID# 279142
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
The Chaim Sheba Medical Center /ID# 275997
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Tel Aviv Sourasky Medical Center /ID# 275852
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting
Hyogo Cancer Center /ID# 276940
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Akashi-shiJapanRecruiting
National Cancer Center Hospital /ID# 276715
Coordinator of this site? Confirm its status
Chuo-KuJapanRecruiting
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 276711
Coordinator of this site? Confirm its status
Koto-kuJapanRecruiting
University of Colorado Hospital- Aurora /ID# 278232
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AuroraUnited StatesRecruiting
Texas Oncology-Austin North /ID# 279958
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AustinUnited StatesRecruiting
University of Cincinnati Medical Center. /ID# 278925
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CincinnatiUnited StatesRecruiting
University Hospitals Cleveland Medical Center /ID# 279601
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ClevelandUnited StatesRecruiting
Next Virginia /ID# 279684
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FairfaxUnited StatesRecruiting
Start Los Angeles /ID# 281533
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Los AngelesUnited StatesRecruiting
University Of Minnesota /ID# 277850
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MinneapolisUnited StatesRecruiting
SCRI Oncology Partners /ID# 279733
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NashvilleUnited StatesRecruiting
OU Health - Stephenson Cancer Center /ID# 277656
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Oklahoma CityUnited StatesRecruiting
Providence Portland Medical Center /ID# 277727
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PortlandUnited StatesRecruiting
Women & Infants Hospital /ID# 277930
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ProvidenceUnited StatesRecruiting
SUNY Upstate Medical University - Syracuse /ID# 277305
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SyracuseUnited StatesRecruiting
Holy Name Medical Center /ID# 279017
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TeaneckUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.