Status:
RECRUITING
A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Conditions:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a clinical study that has two parts. It is testing a potential new medicine called LY4170156 for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at p...
Eligibility Criteria
Inclusion
- Part A and B:
- Have histologically confirmed high-grade serous 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
Key Trial Info
Start Date :
October 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2031
Estimated Enrollment :
1080 Patients enrolled
Trial Details
Trial ID
NCT07213804
Start Date
October 22 2025
End Date
August 1 2031
Last Update
December 17 2025
Active Locations (137)
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1
HonorHealth
Phoenix, Arizona, United States, 85016
2
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
3
Sansum Clinic
Solvang, California, United States, 93463
4
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045