Tests sofetabart mipitecan in adults with platinum-resistant or platinum-sensitive ovarian cancer
Tests sofetabart mipitecan against standard treatments in adults with ovarian cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Athens, Kalamata, and Nea Kifissia, GreeceSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-grade serous or endometrioid ovarian, peritoneal or fallopian tube cancer that has grown again after treatment. It has three parts, for platinum-resistant (Part A) or platinum-sensitive (Parts B and C) disease.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- High-grade serous or endometrioid ovarian, primary peritoneal or fallopian tube cancer, with disease that can be measured on scans (RECIST v1.1) and has grown on or after the last treatment. Part A: platinum-resistant, growth within 6 months of the last platinum treatment. Parts B and C: platinum-sensitive, growth more than 6 months after the last platinum treatment.
- Earlier treatment
- Part A: 1 to 3 earlier lines of chemotherapy (up to 4 if one was mirvetuximab soravtansine); earlier bevacizumab and, with a BRCA mutation, a PARP inhibitor, unless there is a documented reason not to. Parts B and C: relapse after first-line platinum chemotherapy and 1 to 2 earlier lines of chemotherapy. Part B: earlier PARP inhibitor with growth on it or within 6 months of finishing it. Part C: no earlier PARP inhibitor.
- Biomarker or test result
- Tumor tissue block or slides must be available. Part C: no known harmful BRCA1/2 gene change.
Main reasons for not taking part
- Earlier antibody-drug conjugate with a topoisomerase inhibitor payload
- Part A: platinum-refractory disease (growth within 1 month of the last first-line platinum dose)
- Parts B and C: significant protein in the urine (proteinuria)
- Part C: known harmful BRCA1/2 gene change
- Performance status worse than ECOG 0-1
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Have you ever been told you have ovarian, fallopian tube or peritoneal cancer?
- Which best describes your most recent course of platinum chemotherapy (such as carboplatin or cisplatin)?
- What type of ovarian cancer do you have?
Source: NCT07213804, who can take part
Where in Greece
- Alexandra HospitalAthens, GreeceContact: Michalis Liontos (principal investigator)Taking people
- Aretaieio HospitalAthens, GreeceContact: FLORA ZAGOURI (principal investigator)Taking people
- General Hospital of KalamataKalamata, GreeceContact: SOFIA STAMATOPOULOU (principal investigator)Taking people
- General Oncology Hospital of Kifissia "Agioi Anargiroi"Nea Kifissia, GreeceContact: Roubini Zakopoulou (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07213804EU 2025-522255-25-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.
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: 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: 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:; Parts A, B and C:; Have clinically significant proteinuria; Part C:; Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).