A Phase 3 interventional study of Sofetabart Mipitecan and Paclitaxel in Ovarian Neoplasms, Fallopian Tube Neoplasms and Peritoneal Neoplasms, sponsored by Eli Lilly and Company. Recruiting at 264 sites in 27 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 1,630 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part A, B, and C:
Part A:
Part B and C:
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:
Part B and C:
- Have proteinuria
Part C:
- Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered intravenously (IV).
Drug: Sofetabart Mipitecan
Investigator's Choice of Chemotherapy or MIRV given IV.
Drug: Paclitaxel · Drug: Topotecan · Drug: Gemcitabine · Drug: Pegylated liposomal doxorubicin (PLD) · Drug: MIRV
Administered IV.
Drug: Sofetabart Mipitecan · Drug: Bevacizumab
Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.
Drug: Paclitaxel · Drug: Gemcitabine · Drug: Pegylated liposomal doxorubicin (PLD) · Drug: Bevacizumab · Drug: Carboplatin
Administered IV
Drug: Sofetabart Mipitecan · Drug: Bevacizumab
Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.
Drug: Paclitaxel · Drug: Gemcitabine · Drug: Pegylated liposomal doxorubicin (PLD) · Drug: Bevacizumab · Drug: Carboplatin
Administered IV
Also known as: LY4170156, Sofe-M
Administered IV
Administered IV
Administered IV
Administered IV
Administered IV
Administered IV
Administered IV
Progression-free Survival (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 Investigator
Time frame: 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 Blinded, Independent, Central Review (BICR)
Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)
Overall Survival (OS)
Time frame: Randomization to date of death from any cause (up to 70 months)
PFS
PFS by blinded independent central review (BICR)
Time frame: 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)
ORR per RECIST v1.1
Time frame: Randomization to disease progression or death (up to 70 months)
Duration of Response (DOR)
DOR per RECIST v1.1
Time frame: Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)
Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)
DCR per RECIST v1.1
Time frame: Randomization to disease progression or death from any cause (up to 70 months)
PFS2
Time frame: Randomization to disease progression on next line of treatment or death from any cause (up to 70 months)
Time to Initiation of First Subsequent Systemic Anticancer Therapy or Death (TNTD)
Time frame: Randomization to initiation of subsequent systemic anticancer or death from any cause (up to 70 months)
Proportion of Participants with Response of Cancer Antigen-125 (CA-125) per Gynecologic Cancer Intergroup Criteria (GCIG)
Per GCIG
Time frame: Randomization to 30 days post treatment discontinuation
Percentage of Assessments with High Side-effect Bother, as measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT GP5)
FACT-GP5 is a single-item, patient-reported instrument for assessing overall treatment side-effect burden. High side effect bother is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden.
Time frame: Randomization to 30 days post treatment discontinuation
Change from Baseline in Abdominal/GI Symptoms, as measured by the European Organization for Research and Treatment of Cancer Ovarian Cancer Module (EORTC OV28)
The EORTC OV28 consists of 28 items covering 3 functional scales and 5 symptom scales. The Abdominal/GI symptom scale ranges from 0 to 100. Higher scores indicate worse symptoms.
Time frame: Randomization to 30 days post treatment discontinuation
Change from Baseline in Overall Health-related Quality of Life (HRQoL), as measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale
The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-30 Global Health Status/Quality of Life Subscale (two items). Response options range from 0 - 100. Higher score represents better overall HRQoL.
Time frame: Randomization to 30 days post treatment discontinuation
Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156
Time frame: Randomization through end of treatment (up to 70 months)]
PFS
PFS by investigator assessment per RECIST v1.1
Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)
Showing the first 100 of 264 sites across 27 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Bevacizumab