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

Study Identifier
M25-219
CT.gov Identifier
NCT07024784
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Gynecologic Cancer - Other
  • Ovarian Cancer
  • Gynecologic Cancer - Fallopian Tube Cancer
  • Cancer - Other
    • Study Drug
  • IMGN151
  • Carboplatin
  • Bevacizumab
  • Olaparib
    • Phase
    Phase 2
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    * 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Holy Name Medical Center /ID# 279017
    Teaneck, New Jersey, United States, 07666
    Status
    Recruiting
    Location
    University of Cincinnati Medical Center. /ID# 278925
    Cincinnati, Ohio, United States, 45219
    Status
    Recruiting
    Location
    OU Health - Stephenson Cancer Center /ID# 277656
    Oklahoma City, Oklahoma, United States, 73104
    Status
    Recruiting
    Location
    Providence Portland Medical Center /ID# 277727
    Portland, Oregon, United States, 97213
    Status
    Recruiting
    Location
    Women & Infants Hospital /ID# 277930
    Providence, Rhode Island, United States, 02905
    Status
    Recruiting
    Location
    SCRI Oncology Partners /ID# 279733
    Nashville, Tennessee, United States, 37203
    Status
    Recruiting
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