Phase 3 Study of LY4170156 for Ovarian Cancer Resistant or Sensitive to Platinum Treatment

Sponsor: Eli Lilly and Company

Sponsor score: 60

ClinicalTrials ID:NCT07213804

This study is testing a new drug, LY4170156, for ovarian, peritoneal, and fallopian tube cancers. It has two parts: one for cancers that no longer respond to platinum treatments and one for those that still do. The goal is to see if LY4170156 is more effective and safe compared to current treatments.

Patient Parameters

Program Overview

This clinical trial is exploring a new medication called LY4170156 for treating certain types of ovarian, peritoneal, and fallopian tube cancers. The study is divided into two parts: Part A focuses on patients whose cancer does not respond to platinum-based chemotherapy anymore, while Part B includes those whose cancer still responds to such treatments. Researchers aim to determine if LY4170156 is more effective than existing treatments and to assess its safety. The duration of participation in the study will vary based on individual responses to the treatment.

Eligibility Criteria

Inclusion Criteria

Part A and B:

  • Diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
  • Have tumor tissue samples available for testing.
  • Cancer has progressed after the most recent cancer treatment.
  • In good general health, able to carry out daily activities (ECOG score 0-1).
  • Have measurable cancer as per standard criteria.

Part A:

  • Cancer has become resistant to platinum treatments, meaning it progressed within 6 months after the last platinum therapy.
  • Have had 1 to 3 previous chemotherapy treatments, or up to 4 if one included mirvetuximab soravtansine.
  • Have received bevacizumab treatment unless unable to due to medical reasons.
  • Have had treatment with a PARP inhibitor if there is a BRCA mutation, unless unable to due to medical reasons.

Part B:

  • Cancer returned after initial platinum-based chemotherapy and is still sensitive to platinum, meaning it progressed more than 6 months after the last platinum therapy.
  • Have had 1 to 2 previous chemotherapy treatments.
  • Have used a PARP inhibitor and experienced progression during or within 6 months after completing the treatment.

Exclusion Criteria

Part A and B:

  • Have previously received a specific type of drug called an antibody-drug conjugate with a topoisomerase inhibitor.

Part A:

  • Have cancer that did not respond to the first platinum treatment, progressing within 3 months after the last dose.

Part B:

  • Have significant protein in the urine.

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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