Recruiting

IMGN151 for Gynecologic Cancers

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What is being tested

IMGN151

+ Carboplatin

+ Olaparib

Drug
Who is being recruted

Urogenital Diseases+9

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 30, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating the safety and tolerability of a new investigational drug called IMGN151 for treating gynecologic cancers, which includes cancers like ovarian, uterine, and cervical cancer. The aim is to determine how well IMGN151 works on its own and when combined with other cancer treatments. This research is important because it helps to understand if IMGN151 can be a beneficial option for patients with these types of cancers, potentially offering new treatment avenues and improving patient care. Participants in the study receive IMGN151 through intravenous infusions. They are divided into groups, with each group receiving a different treatment combination or monotherapy. Some groups receive IMGN151 with other drugs like carboplatin, olaparib, or bevacizumab, while others receive it alone. The study lasts about three years, during which participants will regularly visit hospitals or clinics for medical assessments, blood tests, and scans. The study may involve a higher treatment burden compared to standard care, but it aims to gather essential data on the drug's effects and safety.

Official TitleA Phase 1b Dose Escalation and Expansion Study of IMGN151 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Subjects With Gynecologic Cancers
NCT07024784
Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

377 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesFallopian Tube DiseasesFallopian Tube NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
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.

4 exclusion criteria prevent from participating
Prior treatment with FRα-targeting therapy.

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.

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.

Prior wide-field radiotherapy affecting more than 20% of the bone marrow.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle.

Group II

Experimental
Participants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle.

Group III

Experimental
Participants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle.

Group IV

Experimental
Participants will receive IMGN151 Day 1 of a 21-day cycle.

Group 5

Experimental
Participants will receive IMGN151 Day 1 of a 21-day cycle.

Group 6

Experimental
Participants will receive IMGN151 Day 1 of a 21-day cycle.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

The Chaim Sheba Medical Center /ID# 275997

Ramat Gan, IsraelOpen The Chaim Sheba Medical Center /ID# 275997 in Google Maps
Recruiting

Tel Aviv Sourasky Medical Center /ID# 275852

Tel Aviv, Israel
Recruiting

Rambam Health Care Campus /ID# 276004

Haifa, Israel
Recruiting

Shaare Zedek Medical Center /ID# 275854

Jerusalem, Israel
Recruiting
7 Study Centers