NCT07213804Recruiting
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Summary
This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard 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.
Inclusion criteria
Part A, B, and C: • Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer. • Have confirmed availability of tumor tissue block or slides • Have radiographic progression on or after most recent line of systemic anticancer therapy • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. • Have measurable disease per RECIST v1.1 Part A: • Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy. • Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine. • Have received prior bevacizumab treatment, unless documented contraindication or intolerance. • Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance. Part B and C: • Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy • Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy Part B: \- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment. Part C: \- Have not previously received a PARPi treatment.
Exclusion criteria
Parts A, B and C: \- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload. Part A: • Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy. Part B and C: \- Have clinically significant proteinuria Part C: \- Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, Greece, Hungary, Ireland, Japan, Mexico, Netherlands, Norway, Poland, Romania, Singapore, South Korea, Spain, Taiwan, United Kingdom
- Sponsor
- Eli Lilly and Company(Industry)
- Protocol no.
- 27727
- Conditions
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis
- Interventions
- Drug
Treatments studied
- Sofetabart Mipitecan
- Paclitaxel
- Topotecan
- Gemcitabine
- Pegylated liposomal doxorubicin (PLD)
- MIRV
- Bevacizumab
- Carboplatin
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT), Asia-Pacific Gynecologic Oncology Trials Group
Locations · 196
- Angers, FranceInstitut de Cancérologie de l'OuestRecruiting at this site
- Bayonne, FranceCentre Hospitalier de la Côte BasqueRecruiting at this site
- Bordeaux, FranceInstitut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecruiting at this site
- Brest, FranceCHRU de BrestRecruiting at this site
- Lille, FranceCentre Oscar LambretRecruiting at this site
- Limoges, FranceCentre Hospitalier Universitaire de Limoges - Hôpital DupuytrenRecruiting at this site
- Lyon Cedex08, FranceCentre Leon BerardRecruiting at this site
- Montpellier, FranceInstitut Régional du Cancer MontpellierRecruiting at this site
- Paris, FranceHopitaux Universitaires Paris Centre-Hopital CochinRecruiting at this site
- Paris, FranceGroupe Hospitalier Diaconesses Croix Saint SimonRecruiting at this site
- Strasbourg, FranceCHU Strasbourg-HautepierreRecruiting at this site
- Aachen, GermanyUniversitätsklinikum AachenRecruiting at this site
- Berlin, GermanyCharité Campus Virchow-KlinikumRecruiting at this site
- Catania, ItalyOspedale CannizzaroRecruiting at this site
- Lucca, ItalyAzienda USL 2 LuccaRecruiting at this site
- Milan, ItalyIstituto Europeo di Oncologia IRCCSRecruiting at this site
- Milan, ItalyOspedale Humanitas San Pio XRecruiting at this site
- Prato, ItalyNuovo Ospedale di Prato-S.StefanoRecruiting at this site
- Innsbruck, AustriaMedizinische Universitaet InnsbruckRecruiting at this site
- Phoenix, United StatesHonorHealthRecruiting at this site
- Burbank, United StatesRoy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical CenterRecruiting at this site
- Duarte, United StatesCity of Hope, DuarteRecruiting at this site
- Irvine, United StatesCity of Hope LennarRecruiting at this site
- Irvine, United StatesKaiser Permanente Zion Medical CenterRecruiting at this site
- Los Angeles, United StatesUCLA Hematology/Oncology - Westwood (Building 100)Recruiting at this site
- Palo Alto, United StatesStanford Women's Cancer CenterRecruiting at this site
- Santa Barbara, United StatesSansum ClinicRecruiting at this site
- Aurora, United StatesAnschutz Cancer PavilionRecruiting at this site
- Farmington, United StatesUConn HealthRecruiting at this site
- Fort Lauderdale, United StatesBroward Health Medical CenterRecruiting at this site
In total, worldwide, 196 of the 265 sites listed in the registry are recruiting; the other 69 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 8, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 166 more locations
Other identifiers
- 2025-522255-25-00 · CTIS number
- J5E-MC-JZXB · other identifier
- GOG-3133 · other identifier
- ENGOT-ov97/GINECO-NOGGO-AGO-A · other identifier
- APGOT-OV17 · other identifier
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.