RecruitingInterventionalPhase 2

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

NCT ID: NCT07024784Sponsor: AbbVieLast updated: 2026-06-02

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.

Arms & interventions

DrugIMGN151
Intravenous (IV) infusion
DrugCarboplatin
Intravenous (IV) infusion
DrugBevacizumab
Intravenous (IV) infusion
DrugOlaparib
Oral Tablet

Outcome measures

Primary

Number of Participants With Dose-limiting Toxicities (DLTs)
Dose limiting toxicities (DLTs) of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time frame: Up to approximately 3 years
Percentage of Participants with Adverse Events (AE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Time frame: Up to approximately 3 years

Secondary

Objective Response (OR)
Time frame: Up to approximately 3 years
Duration of response (DOR)
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
Time frame: Up to approximately 3 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy 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 locations (8)

Holy Name Medical Center /ID# 279017

Teaneck, New Jersey, 07666

Recruiting

University of Cincinnati Medical Center. /ID# 278925

Cincinnati, Ohio, 45219

Recruiting

OU Health - Stephenson Cancer Center /ID# 277656

Oklahoma City, Oklahoma, 73104

Recruiting

Providence Portland Medical Center /ID# 277727

Portland, Oregon, 97213

Recruiting

Women & Infants Hospital /ID# 277930

Providence, Rhode Island, 02905

Recruiting

SCRI Oncology Partners /ID# 279733

Nashville, Tennessee, 37203

Recruiting

Texas Oncology-Austin North /ID# 279958

Austin, Texas, 78758

Recruiting

Next Virginia /ID# 279684

Fairfax, Virginia, 22031

Recruiting