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

Launched by ABBVIE · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called IMGN151 to see how well it works and how safe it is for treating certain gynecologic cancers, including ovarian, fallopian tube, and primary peritoneal cancers. The study will look at how the disease responds to IMGN151 when given alone or combined with other cancer treatments. About 350 adult women will take part in the trial, which will last around three years, with regular visits to the hospital for treatments, tests, and scans.

Women who might join the study should have specific types of gynecologic cancer and generally be in good health with a certain level of physical ability (able to carry out daily activities without major problems). They should have measurable cancer growth and must have completed recent cancer treatments within certain time frames. Participants will be divided into four groups, each receiving IMGN151 either by itself or with different approved cancer medicines. It’s important to know that joining this study may require more frequent medical visits and tests than usual care, and the trial is not yet open for enrollment.

Gender

FEMALE

Eligibility criteria

• 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.