NCT03600649

Phase 1 Trial of the LSD1 Inhibitor Seclidemstat (SP 2577) With and Without Topotecan and Cyclophosphamide in Patients With Relapsed or Refractory Ewing Sarcoma and Select Sarcomas

Status unknown Phase 1 Last updated 20 November 2023

What this trial tests

Phase 1 trial testing Seclidemstat in Ewing Sarcoma in 50 participants. Status unknown.

Timeline

4 June 2018

Primary endpoint
1 September 2025

1 December 2025

Quick facts

Lead sponsor	Salarius Pharmaceuticals, LLC
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	4 June 2018
Primary completion	1 September 2025
Estimated completion	1 December 2025
Sites	16 locations across United States

Drugs / interventions tested

• Seclidemstat — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Topotecan (topotecan) — full drug profile →

Conditions studied

• Ewing Sarcoma — all drugs for Ewing Sarcoma →
• Myxoid Liposarcoma — all drugs for Myxoid Liposarcoma →
• Sarcoma,Soft Tissue — all drugs for Sarcoma,Soft Tissue →
• Desmoplastic Small Round Cell Tumor — all drugs for Desmoplastic Small Round Cell Tumor →

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.

• Safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide measured by dose limiting toxicities and adverse events according to CTCAE version 5.0
  Time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months
  To evaluate the safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide in patients with relapsed or refractory Ewing sarcoma and select sarcomas. Toxicities will be graded in severity per the guidelines outlined in the NCI CTCAE version 5.0. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose l

Sponsor's own description

Single agent, non-randomized, open label expansion in select sarcoma patients including myxoid liposarcoma and other sarcomas that share similar chromosomal translocations to Ewing sarcoma; AND dose expansion of the combination of seclidemstat with topotecan and cyclophosphamide in patients with Ewing sarcoma

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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
2. Targeting epigenetic regulators to overcome drug resistance in cancers.
   Wang N, Ma T, Yu B, Yu B. · · 2023 · cited 213× · PMID 36797239 · DOI 10.1038/s41392-023-01341-7
3. Ewing Sarcoma-Diagnosis, Treatment, Clinical Challenges and Future Perspectives.
   Zöllner SK, Amatruda JF, Bauer S, Collaud S, et al · · 2021 · cited 169× · PMID 33919988 · DOI 10.3390/jcm10081685
4. 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
5. Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
   Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
6. Advances in epigenetic therapeutics with focus on solid tumors.
   Jin N, George TL, Otterson GA, Verschraegen C, et al · · 2021 · cited 87× · PMID 33879235 · DOI 10.1186/s13148-021-01069-7
7. LSD1/KDM1A, a Gate-Keeper of Cancer Stemness and a Promising Therapeutic Target.
   Karakaidos P, Verigos J, Magklara A. · · 2019 · cited 84× · PMID 31756917 · DOI 10.3390/cancers11121821
8. YAP/TAZ drives cell proliferation and tumour growth via a polyamine-eIF5A hypusination-LSD1 axis.
   Li H, Wu BK, Kanchwala M, Cai J, et al · · 2022 · cited 80× · PMID 35177822 · DOI 10.1038/s41556-022-00848-5