Ovarian Cancer Clinical Trial
Official title:
An Open-Label, Phase 1b Study of SL-172154 (SIRPα-Fc-CD40L) Administered With Either Pegylated Liposomal Doxorubicin or Mirvetuximab Soravtansine in Subjects With Platinum-Resistant Ovarian Cancers
SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 patients will be enrolled in this study in two phases: dose escalation and dose expansion.
Study SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate the safety, pharmacokinetics, pharmacodynamic effects, and preliminary anti-tumor activity of SL-172154 administered in combination with either PLD or MIRV in subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. Patients will be appropriate for combination therapy for their next line of therapy. For the SL-172154 + MIRV cohort, patients' tumors must be positive (defined as PS2+ ≥ 25%) for folate receptor alpha (FRα) as defined by the Ventana FOLR1 (Folate Receptor 1/Folate Receptor Alpha) Assay. The first portion of the study will evaluate the safety of increasing dose levels of SL-172154 in combination with either PLD or MIRV and establish a combination dose for both regimens to be further evaluated in two dose expansion cohorts. The study will consist of a 21-day screening period, a study treatment period until at least one of the study treatment discontinuation criteria is met, and a study follow-up period. ;
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