NCT04611139

Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers

Pilot Feasibility and Efficacy Trial of a Novel Reversible LSD1 Inhibitor SP-2577 (Seclidemstat) Plus Pembrolizumab in Select SWI/SNF-mutant Gynecologic Cancers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: HonorHealth Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label study of SF-2577 plus pembrolizumab in advanced, recurrent small cell ovarian cancer as well as select additional ovarian and endometrial cancers within the SWI/SNF pathway.

Detailed description

This study is an open-label, non-randomized dose escalation and expansion study of the LSD inhibitor SP-2577 in combination with the anti PD- 1 antibody pembrolizumab in patients with advanced, recurrent small cell ovarian cancer of the hypercalcemic type (SCCOHT) as well as select additional ovarian and endometrial cancers with mutations in the genes within the SWI/SNF pathway (Ovarian Clear Cell Cancers (OCCC), Endometrioid Ovarian Cancers (EOC) and Endometrioid Endometrial Cancers (EEC).

Conditions

• SCCOHT
• Ovarian Clear Cell Tumor
• Ovarian Endometrioid Adenocarcinoma
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	SP-2577	Daily oral doses
DRUG	Pembrolizumab	200mg Q3W by IV infusion

Timeline

• Start date: 2021-12-31
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2020-11-02
• Last updated: 2022-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study