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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07213804
The ClinicalTrials.gov registry entry for NCT07213804 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,080 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 389-participant average among 41 other Neoplasm Metastasis trials with a reported enrollment target (178% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.