Clareo Health | 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
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
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Asia-Pacific Gynecologic Oncology Trials Group
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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).
