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
| Registry | NCT07024784 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, sequential, masking: none, treatment |
| Enrollment | 377 (Estimated) |
| Sponsor | AbbVie (Industry); collaborators: GOG Foundation |
| Conditions | Gynecologic Cancers, Platinum-Sensitive Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer (PSOC) |
| Interventions | IMGN151, Carboplatin, Bevacizumab, Olaparib (Drug) |
| Dates | start 2025-07-30, primary completion 2028-01-01 (estimated), completion 2028-02-01 (estimated), first posted 2025-06-17, last updated 2026-10-01 |
| Locations | 21 sites in United States, Israel, Japan |
Related Papers Related Patents Related Grants Related Experts
All trials for Gynecologic Cancers All trials for Platinum-Sensitive Ovarian Cancer All trials of IMGN151 All trials of Carboplatin
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm A: IMGN151 + Carboplatin (For PSOC) | Experimental | Drug: IMGN151; Drug: Carboplatin | Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle. |
| Arm B: IMGN151 + Olaparib (For PSOC) | Experimental | Drug: IMGN151; Drug: Olaparib | Participants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle. |
| Arm C: IMGN151 + Bevacizumab (For PSOC or PROC) | Experimental | Drug: IMGN151; Drug: Bevacizumab | Participants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle. |
| Arm D: IMGN151 Monotherapy (For PSOC) | Experimental | Drug: IMGN151 | Participants will receive IMGN151 Day 1 of a 21-day cycle. |
| Arm E: IMGN151 Monotherapy (For PROC in China) | Experimental | Drug: IMGN151 | Participants will receive IMGN151 Day 1 of a 21-day cycle. |
| Arm F: IMGN151 Monotherapy (For PROC in Japan) | Experimental | Drug: IMGN151 | Participants will receive IMGN151 Day 1 of a 21-day cycle. |
Sex: Female, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Start Los Angeles /ID# 281533 | Los Angeles, California | United States | Recruiting |
| University of Colorado Hospital- Aurora /ID# 278232 | Aurora, Colorado | United States | Recruiting |
| University Of Minnesota /ID# 277850 | Minneapolis, Minnesota | United States | Recruiting |
| Holy Name Medical Center /ID# 279017 | Teaneck, New Jersey | United States | Recruiting |
| SUNY Upstate Medical University - Syracuse /ID# 277305 | Syracuse, New York | United States | Recruiting |
| University of Cincinnati Medical Center. /ID# 278925 | Cincinnati, Ohio | United States | Recruiting |
| University Hospitals Cleveland Medical Center /ID# 279601 | Cleveland, Ohio | United States | Recruiting |
| OU Health - Stephenson Cancer Center /ID# 277656 | Oklahoma City, Oklahoma | United States | Recruiting |
| Providence Portland Medical Center /ID# 277727 | Portland, Oregon | United States | Recruiting |
| Women & Infants Hospital /ID# 277930 | Providence, Rhode Island | United States | Recruiting |
| SCRI Oncology Partners /ID# 279733 | Nashville, Tennessee | United States | Recruiting |
| Texas Oncology-Austin North /ID# 279958 | Austin, Texas | United States | Recruiting |
| Next Virginia /ID# 279684 | Fairfax, Virginia | United States | Recruiting |
| Rabin Medical Center /ID# 279142 | Petah Tikva, Central District | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 275997 | Ramat Gan, Tel Aviv | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 275852 | Tel Aviv, Tel Aviv | Israel | Recruiting |
| Rambam Health Care Campus- Haifa /ID# 276004 | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center /ID# 275854 | Jerusalem | Israel | Recruiting |
| Hyogo Cancer Center /ID# 276940 | Akashi-shi, Hyōgo | Japan | Recruiting |
| National Cancer Center Hospital /ID# 276715 | Chuo-Ku, Tokyo | Japan | Recruiting |
| The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 276711 | Koto-ku, Tokyo | Japan | Recruiting |