NCT07024784RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 377 (estimated)
- First submitted
- 9 Jun 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- AbbVie
- Diseases
- Ovarian cancer
- NCT number
- NCT07024784
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 377
- From 30 Jul 2025 to the primary completion date, 31 Jan 2028
- 21 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with FRα-targeting therapy.
- Prior wide-field radiotherapy affecting more than 20% of the bone marrow.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Health Care Campus- Haifa /ID# 276004 Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center /ID# 275854 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Rabin Medical Center /ID# 279142 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 275997 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 275852 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Hyogo Cancer Center /ID# 276940 Coordinator of this site? Confirm its status | Akashi-shi | Japan | Recruiting |
| National Cancer Center Hospital /ID# 276715 Coordinator of this site? Confirm its status | Chuo-Ku | Japan | Recruiting |
| The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 276711 Coordinator of this site? Confirm its status | Koto-ku | Japan | Recruiting |
| University of Colorado Hospital- Aurora /ID# 278232 Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Texas Oncology-Austin North /ID# 279958 Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| University of Cincinnati Medical Center. /ID# 278925 Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| University Hospitals Cleveland Medical Center /ID# 279601 Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Next Virginia /ID# 279684 Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Start Los Angeles /ID# 281533 Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University Of Minnesota /ID# 277850 Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| SCRI Oncology Partners /ID# 279733 Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| OU Health - Stephenson Cancer Center /ID# 277656 Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Providence Portland Medical Center /ID# 277727 Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Women & Infants Hospital /ID# 277930 Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| SUNY Upstate Medical University - Syracuse /ID# 277305 Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Holy Name Medical Center /ID# 279017 Coordinator of this site? Confirm its status | Teaneck | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.