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
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
18 Years and older, Male and Female
27727 (primary)
NCI-2026-00146
2025-522255-25-00
APGOT-OV17
ENGOT-ov97/GINECO-NOGGO
GOG-3133
J5E-MC-JZXB
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
- 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).
Treatment Sites in Georgia
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