Study on the Effects and Safety of IMGN151 for Gynecologic Cancers, Alone or with Other Treatments
Sponsor: AbbVie
ClinicalTrials ID:NCT07024784
This clinical trial is testing the safety and effects of a new drug, IMGN151, for treating gynecologic cancers. The study involves different treatment groups, where participants receive IMGN151 alone or combined with other cancer therapies.
Patient Parameters
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Program Overview
The study aims to evaluate how safe and tolerable the investigational drug IMGN151 is when used alone or with other cancer treatments in adults with gynecologic cancers. Participants will be divided into four groups, each receiving a different treatment plan. The study will include about 377 participants from around the world, and it will last approximately three years. Participants will receive IMGN151 through an IV, either by itself or with other drugs like carboplatin, olaparib, or bevacizumab, depending on their assigned group. Regular hospital or clinic visits will be required for medical check-ups, blood tests, and scans.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have at least one measurable tumor, except for certain ovarian cancer patients who have not shown disease progression after standard platinum therapy.
- Must have high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers.
- Must have completed previous cancer treatments within specific timeframes before starting the study:
- Systemic cancer therapy must be completed at least 5 half-lives or 4 weeks before the first dose of IMGN151.
- Localized radiation therapy must be completed at least 2 weeks before the first dose of the study treatment.
Exclusion Criteria
- Cannot have ovarian cancer with certain types of cell structures, such as endometrioid, clear cell, mucinous, or sarcomatous, or mixed tumors with these types.
- Cannot have any significant medical conditions that would interfere with participation or make them unsuitable for the study.
- Cannot have had previous treatments targeting the FRα protein.
- Cannot have had extensive radiation therapy affecting more than 20% of the bone marrow.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Holy Name Medical Center /ID# 279017 | 07666 | Teaneck | New Jersey |
| University of Cincinnati Medical Center. /ID# 278925 | 45219 | Cincinnati | Ohio |
| Providence Portland Medical Center /ID# 277727 | 97213 | Portland | Oregon |
| Women & Infants Hospital /ID# 277930 | 02905 | Providence | Rhode Island |
| SCRI Oncology Partners /ID# 279733 | 37203 | Nashville | Tennessee |
| Texas Oncology-Austin North /ID# 279958 | 78758 | Austin | Texas |
| Next Virginia /ID# 279684 | 22031 | Fairfax | Virginia |
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