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
- Copenhagen and Vejle, DenmarkSee the 2 sites
- Phase
- Phase 3
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 Denmark
- RigshospitaletCopenhagen, DenmarkTaking people
- Vejle SygehusVejle, DenmarkTaking 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?
Trial 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).