Actively Recruiting
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
Led by AbbVie · Updated on 2026-06-02
377
Participants Needed
16
Research Sites
4 weeks
Total Duration
On this page
Sponsors
A
AbbVie
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying gynecologic cancers, including ovarian, fallopian tube, and primary peritoneal cancers, to evaluate the safety and tolerability of IMGN151 given alone or with other anti-cancer therapies. This Phase 1b trial involves adult female participants and aims to understand how IMGN151 works in combination with treatments like carboplatin, olaparib, and bevacizumab, or by itself. Approximately 377 participants will take part worldwide. Participants are divided into one of six groups, each receiving different treatments. Some groups receive IMGN151 combined with carboplatin, olaparib, or bevacizumab, while others receive IMGN151 alone. Treatments are given as intravenous infusions on Day 1 of each 21-day cycle, with olaparib taken orally twice a day in one group. The study lasts about three years. During the study, participants attend regular hospital or clinic visits for medical check-ups, blood tests, and scans to monitor health and treatment effects. Researchers will track side effects and dose-related toxicities, along with responses to treatment and disease progression over the study period. The goal is to gather detailed information about how participants tolerate these treatments and how their cancers respond.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers
- At least one measurable lesion by RECIST v1.1 (except certain PSOC participants in Arms B and D)
- Completed prior systemic antineoplastic therapy within 5 half-lives or 4 weeks before first IMGN151 dose
- Completed focal radiation at least 2 weeks before first dose of study treatment
You will not qualify if you...
- Ovarian cancer with endometrioid, clear cell, mucinous, sarcomatous histology, mixed tumors with these histologies, low-grade or borderline ovarian tumors
- History of significant medical conditions or other reasons making participation unsuitable
- Prior treatment with FRα-targeting therapy
- Prior wide-field radiotherapy affecting more than 20% of bone marrow
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive intravenous infusions of IMGN151 alone or in combination with other therapies every 21 days as part of their cancer treatment.
Visits every 21 days for infusions and assessments
Duration - Up to approximately 3 years
Participants are monitored for safety and disease status after completing treatment.
Periodic visits during follow-up
Trial Site Locations
Total: 16 locations
1
Holy Name Medical Center /ID# 279017
Teaneck, New Jersey, United States, 07666
Actively Recruiting
2
University of Cincinnati Medical Center. /ID# 278925
Cincinnati, Ohio, United States, 45219
Actively Recruiting
3
OU Health - Stephenson Cancer Center /ID# 277656
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
4
Providence Portland Medical Center /ID# 277727
Portland, Oregon, United States, 97213
Actively Recruiting
5
Women & Infants Hospital /ID# 277930
Providence, Rhode Island, United States, 02905
Actively Recruiting
6
SCRI Oncology Partners /ID# 279733
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
Texas Oncology-Austin North /ID# 279958
Austin, Texas, United States, 78758
Actively Recruiting
8
Next Virginia /ID# 279684
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Rabin Medical Center /ID# 279142
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
10
The Chaim Sheba Medical Center /ID# 275997
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
11
Tel Aviv Sourasky Medical Center /ID# 275852
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
12
Rambam Health Care Campus- Haifa /ID# 276004
Haifa, Israel, 3109601
Actively Recruiting
13
Shaare Zedek Medical Center /ID# 275854
Jerusalem, Israel, 9103102
Actively Recruiting
14
Hyogo Cancer Center /ID# 276940
Akashi-shi, Hyōgo, Japan, 673-8558
Actively Recruiting
15
National Cancer Center Hospital /ID# 276715
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
16
The Cancer Institute Hospital Of JFCR /ID# 276711
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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