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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: IMGN151 + Carboplatin (For PSOC) 		Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle.
  • Drug: IMGN151
    Intravenous (IV) infusion
  • Drug: Carboplatin
    Intravenous (IV) infusion
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.
  • Drug: IMGN151
    Intravenous (IV) infusion
  • Drug: Olaparib
    Oral Tablet
Experimental
Arm C: IMGN151 + Bevacizumab (For PSOC or PROC) 		Participants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle.
  • Drug: IMGN151
    Intravenous (IV) infusion
  • Drug: Bevacizumab
    Intravenous (IV) infusion
Experimental
Arm D: IMGN151 Monotherapy (For PSOC) 		Participants will receive IMGN151 Day 1 of a 21-day cycle.
  • Drug: IMGN151
    Intravenous (IV) infusion
Experimental
Arm E: IMGN151 Monotherapy (For PROC in China) 		Participants will receive IMGN151 Day 1 of a 21-day cycle.
  • Drug: IMGN151
    Intravenous (IV) infusion
Experimental
Arm F: IMGN151 Monotherapy (For PROC in Japan) 		Participants will receive IMGN151 Day 1 of a 21-day cycle.
  • Drug: IMGN151
    Intravenous (IV) infusion

Recruiting Locations

Holy Name Medical Center /ID# 279017
Teaneck, New Jersey 07666

Providence Portland Medical Center /ID# 277727
Portland, Oregon 97213

Women & Infants Hospital /ID# 277930
Providence, Rhode Island 02905

SCRI Oncology Partners /ID# 279733
Nashville, Tennessee 37203

Next Virginia /ID# 279684
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.