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

Purpose

This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (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 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

  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Neoplasm Metastasis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: Sofetabart Mipitecan
Administered intravenously (IV).
  • Drug: Sofetabart Mipitecan
    Administered IV
    Other names:
    • LY4170156
Active Comparator
Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)
Investigator's Choice of Chemotherapy or MIRV given IV.
  • Drug: Paclitaxel
    Administered IV
  • Drug: Topotecan
    Administered IV
  • Drug: Gemcitabine
    Administered IV
  • Drug: Pegylated liposomal doxorubicin (PLD)
    Administered IV
  • Drug: MIRV
    Administered IV
Experimental
Part B: LY4170156 plus Bevacizumab
Administered IV.
  • Drug: Sofetabart Mipitecan
    Administered IV
    Other names:
    • LY4170156
  • Drug: Bevacizumab
    Administered IV
Active Comparator
Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab
Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.
  • Drug: Paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
  • Drug: Pegylated liposomal doxorubicin (PLD)
    Administered IV
  • Drug: Bevacizumab
    Administered IV
  • Drug: Carboplatin
    Administered IV

Recruiting Locations

Sansum Clinic
Santa Barbara, California 93105

Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
Contact:
904.202.7300

Illinois Cancer Specialists
Arlington Heights, Illinois 60005
Contact:
847-259-4482

Trials 365
Shreveport, Louisiana 71103

Sinai Hospital Of Baltimore
Baltimore, Maryland 21215
Contact:
4106019083

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
269-382-2500

The Center of Hope
Reno, Nevada 89511
Contact:
775-327-4673

Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
Contact:
212-731-6455

Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
Contact:
212-731-6455

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
6468884227

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
937-438-7819

Oncology Hematology Care Inc
Cincinnati, Ohio 45242
Contact:
513-751-2273 x22401

The Mark H Zangmeister Center
Columbus, Ohio 43219

USO - Oncology Associates of Oregon, P. C.
Eugene, Oregon 97401

Kaiser Permanente Interstate Medical Office Central
Portland, Oregon 97227
Contact:
5032493315

USO-Texas Oncology-Central/South Texas
Austin, Texas 78731

US Oncology
The Woodlands, Texas 77380

USO - Texas Oncology Gulf Coast
Webster, Texas 77598-4420
Contact:
281-332-7505

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com