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Sofetabart Mipitecan

Phase 3

Ovarian Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jul 17, 2026

Success Probability
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,630
FDA Designations
BREAKTHROUGH_THERAPY
Clinical trial landscape

Sofetabart Mipitecan · 1 trial · 4 indications

Phase 3 1
NCT07213804A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian CancerOvarian Neoplasms
RECRUITING1,630 Analytics
PHASE3RECRUITING
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
Ovarian NeoplasmsUnlock trial analytics
Study Endpoints
Primary Endpoints
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Randomization to radiographic progression or death from any cause (up to 70 months)

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)
Randomization to radiographic progression or death from any cause (up to 70 months)
Secondary Endpoints
Overall Survival (OS)
Randomization to date of death from any cause (up to 70 months)
PFS
Randomization to radiographic progression or death from any cause (up to 70 months)
Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Randomization to disease progression or death (up to 70 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Sofetabart MipitecanEXPERIMENTALAdministered intravenously (IV).
Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)ACTIVE_COMPARATORInvestigator's Choice of Chemotherapy or MIRV given IV.
Part B: Sofetabart Mipitecan plus BevacizumabEXPERIMENTALAdministered IV.
Part B: Platinum-based Doublet Chemotherapy plus BevacizumabACTIVE_COMPARATORInvestigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.
Part C: Sofetabart Mipitecan plus BevacizumabEXPERIMENTALAdministered IV
Part C: Platinum-based Doublet Chemotherapy plus BevacizumabACTIVE_COMPARATORInvestigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.
Interventions
NameTypeDescription
Sofetabart MipitecanDRUGAdministered IV
PaclitaxelDRUGAdministered IV
TopotecanDRUGAdministered IV
GemcitabineDRUGAdministered IV
Pegylated liposomal doxorubicin (PLD)DRUGAdministered IV
MIRVDRUGAdministered IV
BevacizumabDRUGAdministered IV
CarboplatinDRUGAdministered IV
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites266

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 anti...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaChinaCzechiaDenmarkFranceGermanyGreeceHungaryIrelandItalyJapanMexicoNetherlandsNorwayPolandRomaniaSouth KoreaSpainSwitzerlandTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJul 17, 2026NCT07213804lastUpdatePostDate: changed
LOWJul 17, 2026NCT07213804lastUpdatePostDate: changed
LOWJul 7, 2026NCT07213804lastUpdatePostDate: changed
LOWJul 7, 2026NCT07213804lastUpdatePostDate: changed
MEDIUMJun 16, 2026NCT07213804Enrollment: 1080 → 1630
MEDIUMJun 16, 2026NCT07213804Enrollment: 1080 → 1630
MEDIUMJun 16, 2026NCT07213804Enrollment: 1080 → 1630
MEDIUMJun 16, 2026NCT07213804Enrollment: 1080 → 1630
LOWMay 28, 2026NCT07213804lastUpdatePostDate: changed
LOWMay 28, 2026NCT07213804lastUpdatePostDate: changed
LOWMay 26, 2026NCT07213804primaryCompletionDate: changed
LOWMay 24, 2026NCT07213804studyFirstPostDate: changed