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

Part of paid clinical trials in Teaneck, New Jersey.

Sponsor
AbbVie
Study ID
NCT07024784
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fallopian Tube Cancer
  • Gynecologic Cancers
  • Platinum-Sensitive Ovarian Cancer
  • Primary Peritoneal Cancer (PSOC)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMGN151 — DRUG
    Intravenous (IV) infusion
  • Carboplatin — DRUG
    Intravenous (IV) infusion
  • Bevacizumab — DRUG
    Intravenous (IV) infusion
  • Olaparib — DRUG
    Oral Tablet

Study Details

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.

Key Dates

Start date
Jul 30, 2025
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
377 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: IMGN151 + Carboplatin (For PSOC)
    Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle.
  • Experimental: Arm B: IMGN151 + Olaparib (For PSOC)
    Participants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle.
  • Experimental: Arm C: IMGN151 + Bevacizumab (For PSOC or PROC)
    Participants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle.
  • Experimental: Arm D: IMGN151 Monotherapy (For PSOC)
    Participants will receive IMGN151 Day 1 of a 21-day cycle.
  • Experimental: Arm E: IMGN151 Monotherapy (For PROC in China)
    Participants will receive IMGN151 Day 1 of a 21-day cycle.
  • Experimental: Arm F: IMGN151 Monotherapy (For PROC in Japan)
    Participants will receive IMGN151 Day 1 of a 21-day cycle.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Up to approximately 3 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Holy Name Medical Center /ID# 279017TeaneckNew Jersey07666-
University of Cincinnati Medical Center. /ID# 278925CincinnatiOhio45219-
OU Health - Stephenson Cancer Center /ID# 277656Oklahoma CityOklahoma73104-
Providence Portland Medical Center /ID# 277727PortlandOregon97213-
Women & Infants Hospital /ID# 277930ProvidenceRhode Island02905-
SCRI Oncology Partners /ID# 279733NashvilleTennessee37203-
Texas Oncology-Austin North /ID# 279958AustinTexas78758-
Next Virginia /ID# 279684FairfaxVirginia22031-

Find similar trials in Teaneck, NJ

By research site
Holy Name Medical Center· Teaneck, NJUniversity of Cincinnati Medical Center.· Cincinnati, OHOU Health - Stephenson Cancer Center· Oklahoma City, OKProvidence Portland Medical Center· Portland, ORWomen & Infants Hospital· Providence, RISCRI Oncology Partners· Nashville, TN

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