NCT05483933

Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Shattuck Labs, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Platinum-resistant Ovarian Cancer
• Fallopian Tube Cancer
• Epithelial Ovarian Cancer
• Ovarian Cancer
• Platinum-Resistant Fallopian Tube Carcinoma
• Platinum-Resistant Primary Peritoneal Carcinoma
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Pegylated Liposomal Doxorubicin + SL-172154	The investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
DRUG	Mirvetuximab + SL-172154	The investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.

Timeline

• Start date: 2022-08-18
• Primary completion: 2025-02-07
• Completion: 2025-02-07
• First posted: 2022-08-02
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

21 sites across 4 countries: United States, Canada, Spain, United Kingdom

Regulatory

• FDA-regulated drug study