Purpose

This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard 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

Eligibility

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

Inclusion Criteria

Part A, B, and C: - Have histologically confirmed high-grade serous or 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 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic 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 and C: - 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 to 2 prior lines of systemic cytotoxic chemotherapy Part B: - Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment. Part C: - Have not previously received a PARPi treatment.

Exclusion Criteria

Parts A, B and C: - Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload. Part A: - Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy. Part B and C: - Have clinically significant proteinuria Part C: - Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).

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
    • Sofe-M
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: Sofetabart Mipitecan plus Bevacizumab
Administered IV.
  • Drug: Sofetabart Mipitecan
    Administered IV
    Other names:
    • LY4170156
    • Sofe-M
  • 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
Experimental
Part C: Sofetabart Mipitecan plus Bevacizumab
Administered IV
  • Drug: Sofetabart Mipitecan
    Administered IV
    Other names:
    • LY4170156
    • Sofe-M
  • Drug: Bevacizumab
    Administered IV
Active Comparator
Part C: 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

Vanderbilt University Medical Center
Nashville, Tennessee 37232

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.