RecruitingPhase 2NCT07024784

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

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


Sponsor

AbbVie

Enrollment

377 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called IMGN151 — alone or in combination with other cancer treatments — in women with advanced ovarian, fallopian tube, or primary peritoneal cancer to evaluate how well it works and how safe it is. **You may be eligible if...** - You are in good health (ECOG 0–1) - You have been diagnosed with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer - You have at least one measurable tumor visible on imaging (in most cases) - You have completed prior therapy within the specified time windows before starting this study **You may NOT be eligible if...** - Your ovarian cancer is a specific subtype: endometrioid, clear cell, mucinous, sarcomatous, low-grade, or borderline - You have another serious medical condition that your doctor determines would interfere with your participation or safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIMGN151

Intravenous (IV) infusion

DRUGCarboplatin

Intravenous (IV) infusion

DRUGBevacizumab

Intravenous (IV) infusion

DRUGOlaparib

Oral Tablet


Locations(14)

Holy Name Medical Center /ID# 279017

Teaneck, New Jersey, United States

Providence Portland Medical Center /ID# 277727

Portland, Oregon, United States

Women & Infants Hospital /ID# 277930

Providence, Rhode Island, United States

SCRI Oncology Partners /ID# 279733

Nashville, Tennessee, United States

Texas Oncology-Austin North /ID# 279958

Austin, Texas, United States

Next Virginia /ID# 279684

Fairfax, Virginia, United States

Rabin Medical Center /ID# 279142

Petah Tikva, Central District, Israel

The Chaim Sheba Medical Center /ID# 275997

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 275852

Tel Aviv, Tel Aviv, Israel

Rambam Health Care Campus- Haifa /ID# 276004

Haifa, Israel

Shaare Zedek Medical Center /ID# 275854

Jerusalem, Israel

Hyogo Cancer Center /ID# 276940

Akashi-shi, Hyōgo, Japan

National Cancer Center Hospital /ID# 276715

Chuo-Ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 276711

Koto-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07024784


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