NCT06016270

A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer

A Phase Ib/II Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: STCube, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer.

Detailed description

The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage method.

Conditions

• Extensive Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	hSTC810 400 mg + Paclitaxel	hSTC810 400 mg and paclitaxel 175 mg/m2 will be administered as an intravenous (IV) infusion Paclitaxel: 175 mg/m2 will be administered as an IV infusion
DRUG	hSTC810 800 mg + Paclitaxel	hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion

Timeline

• Start date: 2024-02-13
• Primary completion: 2025-01-23
• Completion: 2025-08-25
• First posted: 2023-08-29
• Last updated: 2025-09-05

Locations

8 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study