Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18+
Trial acronym
FRAmework-01
Clinical summary
Summary
This is a clinical study that has two parts. It is testing a potential new medicine called sofetabart mipitecan (also called LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers.
Part A
This part looks at participants whose cancer no longer response to platinum-based treatments (a type of chemotherapy). Participants will be randomly allocated (by chance) to receive either:
- Sofetabart mipitecan intravenously (IV), or
- Investigator's choice of either Chemotherapy IV or mirvetuximab soravtansine (MIRV).
Part B
Looks at participants whose cancer still responds to platinum-based treatments. Participants will be randomly allocated to receive either:
- Sofetabart mipitecan IV with bevacizumab IV, or
- Platinum doublet chemotherapy followed bevacizumab
The researchers want to find out if sofetabart mipitecan works better than the usual 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.
Conditions
This trial is treating people with high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer
Eligibility
Inclusion
Part A and B:
- Have histologically confirmed high-grade serous or high-grade 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 greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior 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:
- 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 but ≤2 prior lines of systemic cytotoxic chemotherapy
- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.
Exclusion
Part A and B:
- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.
Part A:
- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy.
Part B:
- Have clinically significant proteinuria
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
- NCT07213804 *
- 2025-522255-25-00 *
- 27727; J5E-MC-JZXB; GOG-3133; ENGOT-OV97/GINECO-NOGGO; APGOT-OV17
Trial sponsor
Eli Lilly and Company
Scientific Title
A Two-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.
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