Recruiting
Phase 3

LY4170156

Sponsor:

Eli Lilly and Company

Code:

NCT07213804

Conditions

Ovarian Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Neoplasm Metastasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sofetabart Mipitecan

Paclitaxel

Topotecan

Gemcitabine

Pegylated liposomal doxorubicin (PLD)

Study Details

Brief summary:

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

Ovarian Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Neoplasm Metastasis

Study ID

NCT07213804

Start date

Oct 22, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1630 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Sofetabart Mipitecan

Administered intravenously (IV).

active comparator: Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)

Investigator's Choice of Chemotherapy or MIRV given IV.

experimental: Part B: Sofetabart Mipitecan plus 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.

experimental: Part C: Sofetabart Mipitecan plus 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.

Interventions

Sofetabart Mipitecan

Administered IV

Paclitaxel

Administered IV

Topotecan

Administered IV

Gemcitabine

Administered IV

Pegylated liposomal doxorubicin (PLD)

Administered IV

MIRV

Administered IV

Bevacizumab

Administered IV

Carboplatin

Administered IV

Primary outcome measure

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [ Time Frame: Randomization to radiographic progression or death from any cause (up to 70 months) ]
  • PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR) [ Time Frame: Randomization to radiographic progression or death from any cause (up to 70 months) ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

HonorHealth

Recruiting

Phoenix, Arizona, United States, 85016

Principal Investigator:

Lyndsay Willmott

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center

Recruiting

Burbank, California, United States, 91505

Contacts

818-748-4726

Principal Investigator:

Diana Pearre

Kaiser Permanente Zion Medical Center

Recruiting

Irvine, California, United States, 92618

Contacts

714-393-6482

Principal Investigator:

Devansu Tewari

UCLA Hematology/Oncology - Westwood (Building 100)

Recruiting

Los Angeles, California, United States, 90095

Contacts

310-794-3639

Principal Investigator:

Ritu Salani

Stanford Women's Cancer Center

Recruiting

Palo Alto, California, United States, 94305

Principal Investigator:

Kristin Bixel

Sansum Clinic

Recruiting

Santa Barbara, California, United States, 93105

Principal Investigator:

Eric Bank

UConn Health

Recruiting

Farmington, Connecticut, United States, 06030-8010

Contacts

860-679-2100

Principal Investigator:

Jennifer Jorgensen

Broward Health Medical Center

Recruiting

Fort Lauderdale, Florida, United States, 33316

Principal Investigator:

Scott Jordan

Florida Cancer Specialist- South

Recruiting

Fort Myers, Florida, United States, 33901

Principal Investigator:

Elizabeth Guancial

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

904-202-7300

Principal Investigator:

Lauren Hand

University of Miami Hospital and Clinics, Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Abdulrahman Sinno

Mount Sinai Braman Comprehensive Cancer Center

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

305-535-3358

Principal Investigator:

Brian Slomovitz

Florida Cancer Specialist- East

Recruiting

West Palm Beach, Florida, United States, 33401

Principal Investigator:

Bradley Monk

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Beryl Manning-Geist

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Contacts

847-259-4482

Principal Investigator:

Urszula Sobol

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Emma Barber

OSF Saint Fracis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Principal Investigator:

Michelle Rowland

Franciscan Health

Recruiting

Indianapolis, Indiana, United States, 46237

Principal Investigator:

Nibal Saad

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

859-278-5671

Principal Investigator:

Hope Cottrill

Norton Women's and Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40207

Principal Investigator:

Monica Vetter

Trials 365

Recruiting

Shreveport, Louisiana, United States, 71103

Principal Investigator:

Destin Black

Maine Medical Center - Scarborough Campus

Recruiting

Scarborough, Maine, United States, 04074

Principal Investigator:

Leslie Bradford

Greater Baltimore Medical Center

Recruiting

Baltimore, Maryland, United States, 21204

Principal Investigator:

Fong Liu

Sinai Hospital Of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

410-601-9083

Principal Investigator:

Pallavi Kumar

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Robert Morris

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

269-382-2500

Principal Investigator:

Anna Hoekstra

University of Missouri Hospital

Recruiting

Columbia, Missouri, United States, 65212

Contacts

573-882-7440

Principal Investigator:

Mark Hunter

Cox Medical Center North

Recruiting

Springfield, Missouri, United States, 65802

Contacts

417-875-3065

Principal Investigator:

Ashley Valenzuela

The Center of Hope

Recruiting

Reno, Nevada, United States, 89511

Contacts

775-327-4673

Principal Investigator:

Peter Lim

Northwell Health/ RJ Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

Principal Investigator:

Veena John

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

212-731-6455

Principal Investigator:

Bhavana Pothuri

Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Contacts

212-731-6455

Principal Investigator:

Bhavana Pothuri

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

646-888-4227

Principal Investigator:

Roisin OCearbhaill

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

919-684-3765

Principal Investigator:

Angeles Secord

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

937-438-7819

Principal Investigator:

Michael Guy

Oncology Hematology Care Inc

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

513-751-2273 x22401

Principal Investigator:

Ajit Gubbi

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

216-444-6601

Principal Investigator:

Kevin Elias

The Mark H Zangmeister Center

Recruiting

Columbus, Ohio, United States, 43219

Principal Investigator:

Emily Whitman

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T

Recruiting

Hilliard, Ohio, United States, 43026

Principal Investigator:

Robert Neff

USO - Oncology Associates of Oregon, P. C.

Recruiting

Eugene, Oregon, United States, 97401

Principal Investigator:

Charles Anderson

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Principal Investigator:

Christopher Darus

Kaiser Permanente Interstate Medical Office Central

Recruiting

Portland, Oregon, United States, 97227

Contacts

503-249-3315

Principal Investigator:

Sandeep Mashru

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

503-494-7999

Principal Investigator:

Elizabeth Munro

University of Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Lainie Martin

Jefferson Health Honickman Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

215-481-6069

Principal Investigator:

Mitchell Edelson

Asplundh Cancer Pavilion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

215-481-6069

Principal Investigator:

Mitchell Edelson

Women & Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Principal Investigator:

Elizabeth Lokich

USO-Texas Oncology-Central/South Texas

Recruiting

Austin, Texas, United States, 78731

Principal Investigator:

Lynne Knowles

US Oncology

Recruiting

The Woodlands, Texas, United States, 77380

Principal Investigator:

SMO Sarah Cannon Research Inst.

USO - Texas Oncology Gulf Coast

Recruiting

Webster, Texas, United States, 77598-4420

Contacts

281-332-7505

Principal Investigator:

Terri Pustilnik

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

801-213-5750

Principal Investigator:

Theresa Werner

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Principal Investigator:

John Liao

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Janelle Sobecki

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Folate Receptor Alpha
  • Antibody-drug Conjugate
  • Platinum-Resistant
  • Platinum-Sensitive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.