OncoMatch/Clinical Trials/NCT07213804
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
Is NCT07213804 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for ovarian neoplasms.
Treatment: Sofetabart Mipitecan · Paclitaxel · Topotecan · Gemcitabine · Pegylated liposomal doxorubicin (PLD) · MIRV · Bevacizumab · Carboplatin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Ovarian Cancer
Biomarker criteria
Excluded: BRCA1 pathogenic mutation
Excluded: BRCA2 pathogenic mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic cytotoxic therapy
radiographic progression on or after most recent line of systemic anticancer therapy
Must have received: platinum-based chemotherapy — first-line
relapsed after first-line platinum-based chemotherapy [Parts B and C]
Cannot have received: antibody-drug conjugate with topoisomerase inhibitor payload
prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload
Cannot have received: systemic cytotoxic therapy
Exception: Up to 4 lines allowed if one is mirvetuximab soravtansine [Part A]
previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines allowed if one is mirvetuximab soravtansine
Cannot have received: PARP inhibitor
Exception: if known to have a somatic or germline BRCA mutation, if clinically indicated, unless documented contraindication or intolerance [Part A]
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
Cannot have received: PARP inhibitor
Have not previously received a PARPi treatment [Part C]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baptist Health Lexington · Lexington, Kentucky
- Norton Women's and Children's Hospital · Louisville, Kentucky
- Ochsner Clinic Foundation · New Orleans, Louisiana
- Trials 365 · Shreveport, Louisiana
- Maine Medical Center - Scarborough Campus · Scarborough, Maine
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07213804 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate with topoisomerase inhibitor payload, systemic cytotoxic therapy, PARP inhibitor disqualifies patients from enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 pathogenic mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 pathogenic mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages