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SP-2577 Seclidemstat

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Decoy Therapeutics Inc.|Trials Updated: Oct 18, 2021

SP-2577 Seclidemstat development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2019

SP-2577 Seclidemstat target and mechanism

ModalitySmall molecule

Also known as LSD1 Inhibitor

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

SP-2577 Seclidemstat clinical trials

SP-2577 Seclidemstat · 1 trial · 1 indication

Phase 1 1
NCT03895684Phase 1 Trial of the LSD1 Inhibitor SP-2577 (Seclidemstat) in Patients With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED23 Analytics
PHASE1COMPLETED
Phase 1 Trial of the LSD1 Inhibitor SP-2577 (Seclidemstat) in Patients With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

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 to 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 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about SP-2577 Seclidemstat

What is SP-2577 Seclidemstat?

SP-2577, also known as seclidemstat, is an investigational small molecule developed by Decoy Therapeutics Inc. (ticker DCOY) for advanced solid tumors. It is an LSD1 inhibitor and has been studied in a single Phase 1 clinical trial that is now completed.

What is SP-2577 Seclidemstat used for?

SP-2577 Seclidemstat has been studied for the treatment of advanced solid tumors. Its clinical development has focused on oncology, and the one completed Phase 1 trial enrolled patients with advanced solid tumors in the United States.

What does SP-2577 Seclidemstat target?

SP-2577 Seclidemstat targets LSD1, also known as lysine-specific demethylase 1. It is described as an LSD1 inhibitor, a small molecule that acts on this epigenetic enzyme. The Phase 1 trial title identifies it as the LSD1 inhibitor SP-2577.

Who makes SP-2577 Seclidemstat?

SP-2577 Seclidemstat is being developed by Decoy Therapeutics Inc., which trades under the ticker DCOY. The company is the sponsor associated with the drug's clinical development program in advanced solid tumors.

What phase is SP-2577 Seclidemstat in?

SP-2577 Seclidemstat is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is SP-2577 Seclidemstat in?

SP-2577 Seclidemstat has been evaluated in one clinical trial, NCT03895684, titled a Phase 1 trial of the LSD1 inhibitor SP-2577 (seclidemstat) in patients with advanced solid tumors. That trial is completed and enrolled 23 patients in the United States.