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SP-2577 Seclidemstat

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Salarius Pharmaceuticals, Inc.|Last Updated: Oct 18, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03895684Phase 1 Trial of the LSD1 Inhibitor SP-2577 (Seclidemstat) in Patients With Advanced Solid TumorsPHASE1 COMPLETED 23 — — Jun 25, 2019Apr 13, 2021Oct 18, 20212 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of SP-2577
From screening through at least 30 days after end of treatment, up to approximately 24 months

Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0

Secondary Endpoints
Determine the maximum tolerated dose of SP-2577
DLTs within the first cycle of therapy (up to 28 days)
Characterization of pharmacokinetics of SP-2577 (area under the concentration time profile)
At protocol defined time points on cycle 1 (each cycle is 28 days), day 1 and 2 and cycle 2, day 1 and 2.
Characterization of pharmacokinetics of SP-2577 (time to maximum plasma concentration)
At protocol defined time points on cycle 1 (each cycle is 28 days), day 1 and 2 and cycle 2, day 1 and 2.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sp-2577EXPERIMENTALTwice-daily administration of oral SP-2577
Interventions
NameTypeDescription
SP-2577 SeclidemstatDRUGDose escalation and dose expansion of SP-2577.
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age ≥ 12 years and weight ≥ 40 kg. * Diagnosis of advanced or recurrent, histologically or cytologically confirmed, solid malignancy that is either metastatic or unresectable. At time of enrollment, subjects must have progressed on, be intolerant of, refuse, or ineligible for,...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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