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

StatusRecruiting
PhasePhase 2
SponsorAbbVie
Started

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Record History

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  1. Trial sites expanded: 16 → 21 locations
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Study sites: 15 to 16v16
  3. Study sites: 14 to 15v15
  4. Site details revised at 1 of 14 sitesv14
  5. Study sites: 13 to 14v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 12 to 13v12
  2. Study sites: 11 to 12v11
  3. Study sites: 10 to 11v10
  4. Re-verified, no change to tracked fieldsv9
  5. Study sites: 7 to 10
    • Secondary endpoints: details revised at 1 of 3 entries
    v8
  6. Study sites: 6 to 7
    • Collaborators expanded, about 2 words
    v7
  7. Study sites: 5 to 6v6
  8. Study sites: 4 to 5v5
  9. Study sites: 3 to 4
    • Primary completion date: Feb 2028 to Jan 2028
    v4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Primary completion date: Jan 2028 to Feb 2028
    • Start date changed from estimate of Aug 24, 2025 to Jul 30, 2025
    v3
  11. Start date: Jul 15, 2025 to Aug 24, 2025
    • Enrollment target: 350 to 377
    • Study completion date: Jan 2028 to Feb 2028
    • Study arms: 4 to 6
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
Ovarian Cancer
1,341 trials monitored
See 94 trials at risk
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 Details
NCT Number NCT07024784
Lead Sponsor AbbVie
Collaborators: GOG Foundation
Conditions
(from sponsor)		 Gynecologic Cancers, Platinum-Sensitive Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer (PSOC)
Related terms Fallopian Tube Neoplasms, Neoplasms
Enrollment 377 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov