A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

Sponsor: Eli Lilly and Company

Sponsor score: 60

ClinicalTrials ID:NCT07213804

This Phase 3 study evaluates LY4170156 in ovarian, peritoneal, and fallopian tube cancer. Participants must have high-grade serous cancer, measurable disease, and ECOG status 0-1. Part A includes those with platinum-resistant cancer, while Part B includes platinum-sensitive cases. Interventions include LY4170156 and standard IV drugs like paclitaxel and bevacizumab. Eligibility requires prior treatments and tumor tissue availability.

Patient Parameters

Program Overview

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 participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if LY4170156 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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

Locations

FACILITYZIPCITYSTATE
HonorHealth85016PhoenixArizona
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center91505BurbankCalifornia
Sansum Clinic93463SolvangCalifornia
Anschutz Cancer Pavilion80045AuroraColorado
Florida Cancer Specialist- South33901Fort MyersFlorida
University of Miami Hospital and Clinics, Sylvester Cancer Center33136MiamiFlorida
Mount Sinai Comprehensive Cancer Center33140Miami BeachFlorida
Moffitt Cancer Center33612TampaFlorida
Florida Cancer Specialist- East33401West Palm BeachFlorida
Kapiolani Medical Center for Women and Children96826HonoluluHawaii

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