Last reviewed · How we verify
NCT05266196
A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)
Phase 1/Phase 2 trial testing Seclidemstat in Ewing Sarcoma in 10 participants. Status unknown.
1 December 2025
Quick facts
| Lead sponsor | Salarius Pharmaceuticals, LLC |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 15 January 2022 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Seclidemstat — full drug profile →
Conditions studied
- Ewing Sarcoma — all drugs for Ewing Sarcoma →
- Myxoid Liposarcoma — all drugs for Myxoid Liposarcoma →
- Desmoplastic Small Round Cell Tumor — all drugs for Desmoplastic Small Round Cell Tumor →
- Extraskeletal Myxoid Chondrosarcoma — all drugs for Extraskeletal Myxoid Chondrosarcoma →
Sponsor
Salarius Pharmaceuticals, LLC — full company profile →
Who can join
12 and older, any sex, with Ewing Sarcoma or Myxoid Liposarcoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Length of time receiving study treatment
Time frame: months on study where patients continue to receive clinical benefit, up to 5 years
Length of time receiving treatment with seclidemstat as single agent or in combination with assigned parent protocol therapy
Sponsor's own description
This rollover protocol allows continued access to seclidemstat (SP-2577) for patients who are still receiving clinical benefit on completed or closed Salarius sponsored studies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2 -
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0 -
Methylation across the central dogma in health and diseases: new therapeutic strategies.
Liu R, Zhao E, Yu H, Yuan C, et al · · 2023 · cited 79× · PMID 37620312 · DOI 10.1038/s41392-023-01528-y -
LSD1 inhibitors for cancer treatment: Focus on multi-target agents and compounds in clinical trials.
Noce B, Di Bello E, Fioravanti R, Mai A. · · 2023 · cited 78× · PMID 36817147 · DOI 10.3389/fphar.2023.1120911 -
Epigenetic regulation in cancer.
Gu M, Ren B, Fang Y, Ren J, et al · · 2024 · cited 54× · PMID 38374872 · DOI 10.1002/mco2.495 -
Pharmacological targeting of the cancer epigenome.
Mabe NW, Perry JA, Malone CF, Stegmaier K. · · 2024 · cited 36× · PMID 38937652 · DOI 10.1038/s43018-024-00777-2 -
Repression of LSD1 potentiates homologous recombination-proficient ovarian cancer to PARP inhibitors through down-regulation of BRCA1/2 and RAD51.
Tao L, Zhou Y, Pan X, Luo Y, et al · · 2023 · cited 25× · PMID 37973845 · DOI 10.1038/s41467-023-42850-x -
Current Role of Topoisomerase I Inhibitors for the Treatment of Mesenchymal Malignancies and Their Potential Future Use as Payload of Sarcoma-Specific Antibody-Drug Conjugates.
Schöffski P, Wang CC, Schöffski MP, Wozniak A. · · 2024 · cited 13× · PMID 38016427 · DOI 10.1159/000535491
Verify or expand the search:
- PubMed search for NCT05266196
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Seclidemstat
Trials testing the same drug.
- NCT04734990 — Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia · Phase 1, PHASE2 · active not recruiting
Other recruiting trials for Ewing Sarcoma
Currently open trials in the same condition.
- NCT07297979 — Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS) · Phase 1 · recruiting
- NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma · Phase 1 · recruiting
- NCT07197554 — A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies · Phase 1 · recruiting
- NCT07188532 — Biologically-Adapted, Dose-Escalated Radiotherapy for the Treatment of Ewing Sarcoma, BEAR Trial · NA · recruiting
- NCT07141862 — Fertility Preservation in Children With Solid Tumors: Detection of Residual Disease by a Sensitive Method · recruiting
Other Salarius Pharmaceuticals, LLC trials
Trials by the same sponsor.
- NCT05979857 — Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's Lymphoma · EARLY_PHASE1 · not yet recruiting
- NCT03895684 — Phase 1 Trial of the LSD1 Inhibitor SP-2577 (Seclidemstat) in Patients With Advanced Solid Tumors · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05266196 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Salarius Pharmaceuticals, LLC
- Last refreshed: 31 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05266196.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing