IMGN151 alone or with carboplatin, olaparib, or bevacizumab for adults with high-grade serous gynecologic cancers
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
This trial tests whether IV IMGN151, given alone or with carboplatin, olaparib, or bevacizumab, can reduce disease activity and be safely tolerated in adults with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 377 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | radiation, bevacizumab |
| Locations | 14 sites (Teaneck, New Jersey and 13 other locations) |
| Trial ID | NCT07024784 on ClinicalTrials.gov |
What this trial studies
This Phase 2, multi-center trial plans to enroll about 377 adults with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer into four treatment arms. Participants receive intravenous IMGN151 as monotherapy or combined with carboplatin, olaparib, or bevacizumab, administered in repeated treatment cycles. The study tracks changes in disease activity (using RECIST v1.1 for most participants), adverse events, and tolerability. Enrollment requires ECOG performance status 0–1 and adherence to timing rules after prior therapies.
Who should consider this trial
Good fit: Adults with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have ECOG 0–1, meet prior therapy timing windows, and (for most arms) have at least one measurable lesion are the intended participants.
Not a fit: Patients with excluded tumor histologies (endometrioid, clear cell, mucinous, or sarcomatous), poor performance status, or who cannot meet prior therapy timing or measurable disease requirements are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, IMGN151 could provide a new treatment option that shrinks tumors or extends response duration with an acceptable safety profile for patients with these gynecologic cancers.
How similar studies have performed: Antibody–drug conjugates and combinations with PARP inhibitors or platinum agents have shown promise in ovarian cancer, but IMGN151 itself remains investigational and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Teaneck, New Jersey and 13 other locations
- Holy Name Medical Center /ID# 279017 — Teaneck, New Jersey, 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 JFCR /ID# 276711 — Koto-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.