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NCT07213804 · ClinicalTrials.gov registry record · Phase 3
A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
A Phase 3 study of Neoplasm Metastasis and Ovarian Neoplasms, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,080
- Enrollment target
- 20
- Study locations
NCT07213804: Recruiting Phase 3 study of Neoplasm Metastasis and Ovarian Neoplasms, sponsored by Eli Lilly and Company.
NCT07213804 is a Phase 3 study of Neoplasm Metastasis and Ovarian Neoplasms that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 1,080 participants, above the 389-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (178% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07213804, a Phase 3 study of Neoplasm Metastasis and Ovarian Neoplasms, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,080 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if Sofetabart Mipitecan works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
Primary Outcome
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG Gemcitabine
- DRUG Topotecan
- DRUG Sofetabart Mipitecan
- DRUG Pegylated liposomal doxorubicin (PLD)
Study Locations (20)
California
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center - Burbank
- City of Hope, Duarte - Duarte
- Moores Cancer Center - La Jolla
- UCLA Hematology/Oncology - Westwood (Building 100) - Los Angeles
- Stanford Women's Cancer Center - Palo Alto
- Kaiser Permanente Zion Medical Center - San Diego
- Sansum Clinic - Santa Barbara
- Kaiser Permanente - Vallejo
Florida
- Broward Health Medical Center - Fort Lauderdale
- Florida Cancer Specialist- South - Fort Myers
- Baptist MD Anderson Cancer Center - Jacksonville
- University of Miami Hospital and Clinics, Sylvester Cancer Center - Miami
- Mount Sinai Comprehensive Cancer Center - Miami Beach
- AdventHealth Orlando - Orlando
- Moffitt Cancer Center - Tampa
Colorado
- Anschutz Cancer Pavilion - Aurora
- AdventHealth Medical Group - Porter - Denver
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- HonorHealth - Phoenix
Connecticut
- UConn Health - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,080 participants |
| Start Date | 2025-10-22 |
| Est. Completion | 2031-08 |
| Phase | Phase 3 |
What NCT07213804 shows while recruiting
NCT07213804 is an interventional study that assigns participants to a tested intervention. Its 1,080 participants enrollment target places it among the larger protocols in the corpus, above the 389-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (178% higher).
The record links to 4 conditions, with Neoplasm Metastasis appearing as the primary indexed condition, and to 5 interventions - of which Paclitaxel is the first listed.
NCT07213804 names 20 study sites across 6 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT07213804 about?
NCT07213804 is a clinical study titled "A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer". This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a t...
What is the current status of trial NCT07213804?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,080 participants. The study started on 2025-10-22. Estimated completion is 2031-08.
What conditions does trial NCT07213804 study?
This clinical trial studies the following conditions: Neoplasm Metastasis, Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms.
What interventions are being tested in trial NCT07213804?
The interventions under investigation include: Paclitaxel (DRUG), Gemcitabine (DRUG), Topotecan (DRUG), Sofetabart Mipitecan (DRUG), Pegylated liposomal doxorubicin (PLD) (DRUG).
Who is sponsoring clinical trial NCT07213804?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07213804 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07213804's enrollment target sits among peer trials
1,080 5th of 41 higher than 37 of 41 other Neoplasm Metastasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasm Metastasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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