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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Daily oral doses
200mg Q3W by IV infusion
HonorHealth Research Institute
Scottsdale, Arizona, United States
Incident of AEs
Incidence of Adverse Events (AEs) as measured by NCI CTCAE version 5.0
Time frame: First dose to 90 days after last dose
Incident of DLTs
Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase
Time frame: First dose to 90 days after last dose
Overall Response Rate
Percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), as determined by Investigator according to Response Evaluation in Solid Tumors (RECIST) v 1.1
Time frame: Study enrollment until participant discontinuation, occurrence of PD or death (approximately 6 months to 3 years)
Disease Control Rate
Percentage of participants with Disease Control (complete response, partial response, or stable disease) as determined by RECIST v1.1
Time frame: Study enrollment until PD or loss of clinical benefit (approximately 6 months to 3 years)
Duration of Response
Duration of Response as determined by the Investigator according to RECIST v1.1
Time frame: Date of first occurrence of objective response to first documentation of PD (approximately 6 months to 3 years)
Duration of Stable Disease
Duration of Stable Disease as determined by the investigator according to RECIST v 1.1
Time frame: Date of first occurrence of stable disease to first documentation of PD (approximately 6 months to 3 years)
Progression Free Survival
Progression Free Survival (PFS) as determined by the Investigator according to RECIST v1.1
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Time frame: Start of treatment to first occurrence of PD or death (approximately 6 months to 3 years)
Overall Survival
Overall Survival (OS) as determined by the Investigator according to RECIST v1.1
Time frame: Start of treatment to death (approximately 2 to 3 years)
Plasma Concentration of SP-2577
Plasma concentration of seclidemstat (SP-2577)
Time frame: 2 months
ctDNA in blood and other body fluids
Proportion of circulating tumor DNA ( ctDNA) in peripheral blood and other body fluids e.g. ascitic fluid
Time frame: 6 months to 2 years
Target Inhibition in Tumor Biopsies
Percentage of target inhibition by seclidemstat and pembrolizumab in tumor tissue biopsy specimens
Time frame: 6 months to 2 years