NCT06922539

ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer

A Phase 1a/1b Trial in Relapsed/Refractory Small Cell Lung Cancer to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg/mL) for Intravenous Infusion

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: SciTech Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates a fenretinide phospholipid suspension for the treatment of small cell lung cancer (SCLC).

Detailed description

Fenretinide has been shown to be a relatively safe and effective anticancer therapy; however, low fenretinide bioavailability and dose limiting toxicities due to excipients used in previous formulations has impeded its therapeutic utility. The product formulation in the current study (ST-001) is a phospholipid suspension of nanoparticle sized fenretinide. The current study is a Phase 1 trial in in relapsed/refractory small cell lung cancer to determine the safety profile, pharmacology, and maximum tolerated dose (MTD) of ST-001.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Fenretinide	Intravenous administration
DRUG	Fenretinide	Intravenous administration

Timeline

• Start date: 2025-12-11
• Primary completion: 2027-05-01
• Completion: 2028-10-01
• First posted: 2025-04-10
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study