NCT02667873

A Trial of a Novel XPO1 Inhibitor in Participants With Advanced Solid Tumors

A Phase 1 Trial of SL-801, a Novel Inhibitor of XPO1 Nuclear Export, in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Stemline Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of orally administered SL-801 in participants with advanced solid tumors.

Detailed description

Study SL-801-0115 is a first-in-human, dose-escalation study in participants with advanced (that is, metastatic or locally advanced and unresectable) solid tumors that are resistant to or relapsed following available standard systemic therapy or for which there is no standard systemic therapy and additional radiation therapy, or other loco-regional therapies are not considered feasible. Eligible participants will be enrolled and receive treatment with SL-801. SL-801 will be administered orally, and the dose regimen will depend on the cohort in which the participant is enrolled. The study plans to enroll approximately 70 adult participants at multiple study centers in the United States.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	SL-801	SL-801 is a small-molecule inhibitor of the nuclear export protein Exportin-1 (XPO1).

Timeline

• Start date: 2016-02-23
• Primary completion: 2021-10-06
• Completion: 2021-10-13
• First posted: 2016-01-29
• Last updated: 2025-02-10

Locations

6 sites across 1 country: United States