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Clinical Trials in Ireland / NCT07213804
Recruiting Phase 3

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

NCT07213804 · tracked via the Priya Life Science Ireland tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2025-10-22
Last updated
2026-09-08

Condition(s) studied

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsNeoplasm Metastasis

Investigational drug(s) / intervention(s)

Sofetabart MipitecanPaclitaxelTopotecanGemcitabinePegylated liposomal doxorubicin (PLD)MIRVBevacizumabCarboplatin

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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).

Primary outcome measure(s)

Trial sites (267)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Not Yet Recruiting
HonorHealth Phoenix Arizona Recruiting
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center Burbank California Recruiting
City of Hope, Duarte Duarte California Not Yet Recruiting
City of Hope Lennar Irvine California Not Yet Recruiting
Kaiser Permanente Zion Medical Center Irvine California Recruiting
Moores Cancer Center La Jolla California Not Yet Recruiting
UCLA Hematology/Oncology - Westwood (Building 100) Los Angeles California Recruiting
Stanford Women's Cancer Center Palo Alto California Recruiting
Sansum Clinic Santa Barbara California Recruiting
Kaiser Permanente Vallejo California Not Yet Recruiting
Anschutz Cancer Pavilion Aurora Colorado Not Yet Recruiting
AdventHealth Medical Group - Porter Denver Colorado Not Yet Recruiting
UConn Health Farmington Connecticut Recruiting
Broward Health Medical Center Fort Lauderdale Florida Recruiting
Florida Cancer Specialist- South Fort Myers Florida Recruiting
Baptist MD Anderson Cancer Center Jacksonville Florida Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida Recruiting
Mount Sinai Braman Comprehensive Cancer Center Miami Beach Florida Recruiting
AdventHealth Orlando Orlando Florida Not Yet Recruiting
Moffitt Cancer Center Tampa Florida Not Yet Recruiting
Florida Cancer Specialist- East West Palm Beach Florida Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia Recruiting
Nancy N. & J.C. Lewis Cancer and Research Pavillion Savannah Georgia Not Yet Recruiting
Kapiolani Medical Center for Women and Children Honolulu Hawaii Not Yet Recruiting
Illinois Cancer Specialists Arlington Heights Illinois Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
Rush University Medical Center Chicago Illinois Not Yet Recruiting
The University of Chicago Medicine Chicago Illinois Not Yet Recruiting
OSF Saint Fracis Medical Center Peoria Illinois Recruiting
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana Not Yet Recruiting
Franciscan Health Indianapolis Indiana Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
University of Kentucky Chandler Medical Center Lexington Kentucky Not Yet Recruiting
Norton Women's and Children's Hospital Louisville Kentucky Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Not Yet Recruiting
Trials 365 Shreveport Louisiana Recruiting
Maine Medical Center - Scarborough Campus Scarborough Maine Recruiting
Greater Baltimore Medical Center Baltimore Maryland Recruiting
Sinai Hospital Of Baltimore Baltimore Maryland Recruiting

+ 227 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07213804 on ClinicalTrials.gov ↗ ← All trials in Ireland